Wednesday, March 22, 2017

TORSERETIC

TORSERETIC 
TORSERETIC - torsemide 5mg-10mg -20mg Tablet TORSERETIC - torsemide 20mg/2m1 Injection DESCRIPTION TORSERETIC (torsemide) is a diuretic of the pyridine-sulfonylurea class. Inactive Ingredient of tablet: lactose monohydrate Microcrystalline cellulose -povidone -Magnesium stearate - Croscarmellose. Inactive Ingredient of ampoule: Polyethylene glycol 400- Tromethamine- Sodium Hydroxide- Water for injection. CLINICAL PHARMACOLOGY Mechanism of Action - Micropuncture studies have shown that torsemide acts from within the lumen of the thick ascending portion of the loop of Henle, where it inhibits the Na+/K+/2C1—carrier system. Clinical pharmacology studies have confirmed this site of action in humans, and effects in other segments of the nephron have not been demonstrated. - Diuretic activity thus correlates better with the rate of drug excretion in the urine than with the concentration in the blood. - Torsemide increases the urinary excretion of sodium, chloride, and water, but it does not significantly alter glomerular filtration rate, renal plasma flow, or acid-base balance. Pharmacoklnetics and Metabolism -The bioavailability of TORSERETIC tablets is approximately 80%, with little inter subject variation; the 90% confidence interval is 75%to 89%. The drug is absorbed with lithe first-pass metabolism, and the serum concentration reaches its peak (Cmax) within 1 hour after oral administration. Cmax and area under the serum concentration-time curve (AUC) after oral administration are proportional to dose over the range of 2.5 mg to 200 mg. -The volume of distribution of torsemide is 12 liters to 15 liters in normal adults or in patients with mild to moderate renal failure or congestive heart failure. In patients with hepatic cirrhosis, the volume of distribution is approximately doubled. -In normal subjects the elimination half-life of torsemide is approximately 3.5 hours. Torsemide is cleared from the circulation by both hepatic metabolism (approximately 80% of total clearance) and excretion into the urine (approximately 20% of total clearance in patients with normal renal function). The major metabolite in humans is the carboxylic acid derivative, which is biologically inactive. Two of the lesser metabolites possess some diuretic activity, but for practical purposes metabolism terminates the action of the drug. -Because torsemide is extensively bound to plasma protein (>99%), very little enters tubular urine via glomerular filtration. Most renal clearance of torsemide occurs via active secretion of the drug by the proximal tubules into tubular urine. -In patients with decompensated congestive heart failure, hepatic and renal clearance are both reduced, probably because of hepatic congestion and decreased renal plasma flow, respectively. The total clearance of torsemide is approximately 50% of that seen in healthy volunteers, and the plasma half-life and AUC are correspondingly increased, Because of reduced renal clearance, a smaller fraction of any given dose is delivered to the intraluminal site of action, so at any given dose there is less natriuresis in patients with congestive heart failure than in normal subjects. -In patients with renal failure, renal clearance of torsemide is markedly decreased but total plasma clearance is not significantly altered A smaller fraction of the administered dose is delivered to the intraluminal site of action, and the natriuretic action of any given dose of diuretic is reduced. A diuretic response in renal failure may still be achieved if patients are given higher doses. The total plasma clearance and elimination half-life of torsemide remain normal under the conditions of impaired renal function because metabolic elimination by the liver remains intact. -In patients with hepatic cirrhosis, the volume of distribution, plasma half-life, and renal clearance are all increased, but total clearance is unchanged. -The pharmacokinetic profile of torsemide in healthy elderly subjects is similar to that in young subjects except for a decrease in renal clearance related to the decline in renal function that commonly occurs with aging. However, total plasma clearance and elimination half-life remain unchanged. INDICATIONS AND USAGE TORSERETIC is indicated for: -The treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. -TORSERETIC intravenous injection is indicated when a rapid onset of diuresis is desired or when oral administration is impractical. -TORSERETIC is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents. CONTRAINDICATIONS TORSERETIC is contraindicated in patients with known hypersensitivity to torsemide or to suffonylureas. TORSERETIC is contraindicated in patients who are anuric.
WARNINGS Hepatic Disease with Cirrhosis and AscItes: -TORSERETIC should be used with caution in patients with hepatic disease with cirrhosis and ascites, since sudden alterations of fluid and electrolyte balance may precipitate hepatic coma. In these patients, diuresis with TORSERETIC (or any other diuretic) is best initiated in the hospital. To prevent hypokalemia and metabolic alkalosis, an aldosterone antagonist or potassium-sparing drug should be used concomitantly with TORSERETIC. Ototoxlcity: -Tinnitus and hearing loss (usually reversible) have been observed after rapid intravenous injection of other loop diuretics and have also been observed after oral TORSERETIC. It is not certain that these events were attributable to TORSERETIC. Administered intravenously, TORSERETIC should be injected slowly over 2 minutes, and single doses should not exceed 200 mg. Volume and Electrolyte Depletion: -Patients receiving diuretics should be observed for clinical evidence of electrolyte imbalance, hypovolemia, or prerenal azotemia. Symptoms of these disturbances may include one or more of the following,
dryness of the mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, nausea, and vomiting.Excessive diuresis may cause dehydration, blood-volume reduction, and possibly thrombosis and embolism, especially in elderly patients. In patients who develop fluid and electrolyte imbalances, hypovolemia, or prerenal azotemia, the observed laboratory changes may include hyper- or hyponatremia, hyper- or hypochloremia, hyper- or hypokalemia, acid-base abnormalities, and increased blood urea nitrogen (BUN). If any of these occur, TORSERETIC should be discontinued until the situation is corrected; TORSERETIC may be restarted at a lower dose. -In patients with cardiovascular disease, especially those receiving digitalis glycosides, diuretic-induced hypokalemia may be a risk factor for the development of arrhythmias. The risk of hypokalemia is greatest in patients with cirrhosis of the liver, in patients experiencing a brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes, and in patients receiving concomitant therapy with corticosteroids or ACTH. -Periodic monitoring of serum potassium and other electrolytes is advised in patients treated with TORSERETIC. PRECAUTIONS Laboratory Values -Potassium :See WARNINGS. -Calcium: Single doses of TORSERETIC increased the urinary excretion of calcium by normal subjects, but serum calcium levels were slightly increased in 4- to 6-week hypertension trials. -Magnesium: Single doses of TORSERETIC caused healthy volunteers to increase their urinary excretion of magnesium, but serum magnesium levels were slightly increased in 4- to 6-week hypertension trials. -Blood Urea Nitrogen (BUN), Creatinine and Uric Acid: TORSERETIC produces small dose-related increases in each of these laboratory values. -Symptomatic gout has been reported in patients receiving TORSERETIC, but its incidence has been similar to that seen in patients receiving placebo. -Glucose: Hypertensive patients who received 10 mg of daily TORSERETIC experienced a mean increase in serum glucose concentration of 5.5 mg/dL (0.3 mmol/L) after 6 weeks of therapy. In long-term studies in diabetics, mean fasting glucose values were not significantly changed from baseline. Cases of hyperglycemia have been reported but are uncommon. -Serum Lipids : Daily doses of 5 mg, 10 mg, and 20 mg of TORSERETIC were associated with increases in total plasma cholesterol of 4. 4, and 8 mg/dL (0.10 to 0.20 mmol/L), respectively. The changes subsided during chronic therapy. -Other: TORSERETIC has been associated with small mean decreases in hemoglobin, hematocrit, and erythrocyte count and small mean increases in white blood cell count, platelet count, and serum alkaline phosphatase. -This product contains lactose which must be used for patients with lactose- galactose intolerance. DRUG INTERACTIONS: -In patients with essential hypertension, TORSERETIC has been administered together with beta-blockers, ACE inhibitors, and calcium-channel blockers. In patients with congestive heart failure, TORSERETIC has been administered together with digitalis glycosides, ACE inhibitors, and organic nitrates. None of these combined uses was associated with new or unexpected adverse events. -Torsemide does not affect the protein binding of glyburide or of warfarin, the anticoagulant effect of phenprocoumon (a related coumarin derivative), or the pharmacokinetics of digoxin or carvedilol (a vasodilator/beta-blocker). -In healthy subjects, coadministration of TORSERETIC was associated with significant reduction in the renal clearance of spironolactone, with corresponding increases in the AUC. However, clinical experience indicates that dosage adjustment of either agent is not required. -Because TORSERETIC and salicylates compete for secretion by renal tubules, patients receiving high doses of salicylates may experience salicylate toxicity when TORSERETIC is concomitantly administered. Also, although possible interactions between torsemide and non steroidal anti-inflammatory agents (including aspirin) have not been studied, coadministration of these agents with another loop diuretic (furosemide) has occasionally been associated with renal dysfunction. -The natriuretic effect of TORSERETIC (like that of many other diuretics) is partially inhibited by the concomitant administration of indomethacin. This effect has been demonstrated for TORSERETIC under conditions of dietary sodium restriction (50 mEq/day) but not in the presence of normal sodium intake (150 mEq/day). -The pharmacokinetic profile and diuretic activity of torsemide are not altered by cimetidine or spironolactone. Coadministration of digoxin is reported to increase the area under the curve for torsemide by 50%, but dose adjustment of TORSERETIC is not necessary. -Concomitant use of torsemide and cholestyramine has not been studied in humans but, in a study in animals, coadministration of cholestyramine decreased the absorption of orally administered torsemide. If TORSERETIC and cholestyramine are used concomitantly, simultaneous administration is not recommended. -Coadministration of probenecid reduced secretion of TORSERETIC into the proximal tubule and thereby decreases the diuretic activity of TORSERETIC. -Other diuretics are known to reduce the renal clearance of lithium, inducing a high risk of lithium toxicity, so coadministration of lithium and diuretics should be undertaken with great caution, if at all. Coadministration of lithium and TORSERETIC has not been studied. -Other diuretics have been reported to increase the ototoxic potential of aminoglycoside antibiotics and of ethacrynic acid, especially in the presence of impaired renal function. PREGNANCY: This drug should be used during pregnancy only if clearly needed. Labor and Delivery The effect of TORSERETIC on labor and delivery is unknown. Nursing Mothers It is not known whether TORSERETIC is excreted in human milk. Because many drugs are excreted in human milk,
caution should be exercised when TORSERETIC is administered to a nursing woman
PEDIATRIC USE: Safety and effectiveness in pediatric patients have not been established.
GERIATRIC USE: No specific age-related differences in effectiveness or safety were observed between younger patients and elderly patients. ADVERSE REACTIONS The most common is dizziness, headache, nausea, weakness, vomiting, hyperglycemia, excessive urination, hyperuricernia, hypokalemia, excessive thirst, hypovolemia, impotence, esophageal hemorrhage, and dyspepsia. Dropout rates for these adverse events ranged from 0.1% to 0.5%. The side effects considered possibly Headache, Excessive Urination, Dizziness, Rhinitis, Asthenia, Diarrhea, ECG Abnormality, Cough Increase, Constipation, Nausea, Arthralgia, Dyspepsia, Sore Throat, Myalgia, Chest Pain, Insomnia, Edema, Nervousness. Serious adverse events reported in the clinical studies for which a drug relationship could not be excluded were atrial fibrillation, chest pain, diarrhea, digitalis intoxication, gastrointestinal hemorrhage, hyperglycemia, hyperuricemia, hypokalemia, hypotension, hypovolemia, shunt thrombosis, rash, rectal bleeding, syncope, and ventricular tachycardia. Angioedema has been reported in a patient exposed to TORSERETIC who was later found to be allergic to sulfa drugs.Arthritis and various other nonspecific musculoskeletal problems were reported . OVERDOSAGE There is no human experience with overdoses of TORSERETIC, but the signs and symptoms of over dosage can be anticipated to be those of excessive pharmacologic effect: dehydration, hypovolemia, hypotension, hyponatremia, hypokalemia, hypochloremic, alkalosis, and hemoconcentration. Treatment of over dosage should consist of fluid and electrolyte replacement DOSAGE AND ADMINISTRATION General -TORSERETIC tablets may be given at any time in relation to a meal, as convenient. Special dosage adjustment in the elderly is not necessary. -Because of the high bioavailability of TORSERETIC, oral and intravenous doses are therapeutically equivalent, so patients may be switched to and from the intravenous form with no change in dose. -TORSERETIC intravenous injection should be administered either slowly as a bolus over a period of 2 minutes or administered as a continuous infusion. -If TORSERETIC is administered through an IV line, it is recommended that, as with other IV injections, the IV line be flushed with Normal Saline (Sodium Chloride Injection, USP) before and after administration. TORSERETIC injection is formulated above pH 8.3.Flushing the line is recommended to avoid the potential for incompatibilities caused by differences in pH which could be indicated by color change, haziness or the formation of a precipitate in the solution. -If TORSERETIC is administered as a continuous infusion, stability has been demonstrated through 24 hours at room temperature in plastic containers for the following fluids and concentrations: 200 mg TORSERETIC (10 mg/mL) added to: 250 mL Dextrose 5% in water 250 mL 0.9% Sodium Chloride 500 mL 0.45% Sodium Chloride 50 mg TORSERETIC (10 mg/mL) added to: 500 mL Dextrose 5% in water 500 mL 0.9% Sodium Chloride 500 mL 0.45% Sodium Chloride Before administration, the solution of TORSERETIC should be visually inspected for discoloration and particulate matter. If either is found, the ampoule should not be used. Congestive Heart Failure The usual initial dose is 10 mg or 20 mg of once-daily oral or intravenous TORSERETIC. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 200 mg have not been adequately studied. Chronic Renal Failure The usual initial dose of TORSERETIC is 20 mg of once-daily oral or Intravenous TORSERETIC. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than200 mg have not been adequately studied. Hepatic Cirrhosis The usual initial dose is 5 mg or 10 mg of once-daily oral or intravenous TORSERETIC, administered together with an aldosterone antagonist or a potassium-sparing diuretic. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 40 should not be used. Hypertension The usual initial dose is 5mg once daily. If the 5mg dose does not provide adequate reduction in blood pressure within 4 to 6 weeks, the dose may be increased to 10 mg once daily. If the response to 10 mg is insufficient, an additional antihypertensive agent should be added to the treatment regimen. PACKAGE: For TORSERETIC 5mg & 10 mg & 20 mg Tablets Carton box containing 1 or 3 transparent PVDC/ AL strips, each strip of 10 tablets insert leaflet For TORSERETIC 20 mg/2ml ampoule Carton box containing 3 clear colorless glass ampoules type II of 2 ml solution with an insert leaflet. PRODUCED BY: Tablets : Future Pharmaceutical Industries for Utopia Pharmaceuticals Ampoules :Sigmatec pharmaceutical industries for utopia pharmaceuticals

Regcor

Regcor
Regcor
For The Medical Profession Only
Regcor@ Tablets
EIPICO
Composition:
Each tablet contains:
Amlodipine (as besylate) 5 or 10 mg
Inactive ingredients: microcrystalline cellulose,
anhydrous, sodium starch glycolate, colloidal
stearate.
Clinical Pharmacology:
calciu
silicon
phosphate dibasic
oxide, magnesjurn
Mechanism of Action: Regcor is a dihydropyridine calcium antagonist (calcium
ion antagonist or slow-channel blocker) that inhibits the trarismembrane influx of
calcium ion into vascular smooth muscle and cardiac musqe. Experimental data
suggest that amlodipine binds to both dihydropyridine and nondihydropyridine
binding The contractile processes of cardiac muscle and vascular smooth
muscle are dependent upon the movement of extracellular calcium ions into
these cells through specific ion channels. Regcor inhibits calcium ion influx
across cell membranes selectively, with a greater effect on vascular smooth
muscle cells than on cardiac muscle cells. Negative inogropjc effects can be
detected in vitro but such effects have not been seen tin intact animals at
therapeutic doses. Serum calcium concentration is not affected by Regcor Within
the physiologic pH range, Regcor is an ionized compound (pKa:8.6), and its
kinetic interaction with the calcium channel receptor i$ characterized by a
gradual rate of association and dissociation with the receptor binding Site,
resulting in a gradual onset of effect.
Regcor is a peripheral. arterial vasodilator that acts directly on vascular smooth
muscle to cause a reduction in peripheral vascular resistance and reduction in
blood pressure.
The precise mechanisms by which Regcor relieves angi have not been fully
delineated, but are thought to include the following:
Exertional Angina: In patients With exertional angina, Regcor reduces the total
peripheral resistance (afterload) against which the heart works and reduces the
rate pressure product, and thus myocardial oxygen deman at any given level of
exercise.
Vasospastic Angina: Regcor has been demonstrated to block constriction and
restore blood flow in coronary arteries and arterioles in response to calcium,
potassium, epinephrine, serotonin, and thromboxane A2 analog in expertrnental
animal models and in human coronary vessels in Vitro. This inhibition of
coronary spasm is responsible for the effectiveness of Regcor in vasospastic
(Prinzmetal's or variant) angina.
Pharmacokinetics and Metabolism: After oral administration of therapeutic-
doses of Regcor, absorption produces peak plasma concentrations between 6
and 12 hours. Absolute bioavailability has been estimated to be between 64 and
90%. The bioavailability of Regcor is not altered by the presence of food.
Regcor is extensively (about 90%) converted to inactive metabolites via hepatic
metabolism with 10% of the parent compound and 60% metabolites excreted in
the urine. Ex vivo studies have shown that approximately 93% of the circulating
drug is bound to plasma proteins in hypertensive patients. Elimination from the
plasma is biphasic with a terminal elimination half-life of about 30 — 50 hours,
Steady-state plasma levels of Regcor are reached after 7 to 8 days of consecutive
daily dosing. The pharmacokinetics of Regcor are not significantly influenced by
renal impairment. Patients with renal failure may therefore receive the usual
initial dose. Elderly patients and patients with hepatic insufficiency have
decreased clearance of amlodipine with a resulting increase in AUC of
approximately 40-60%, and a lower initial dose may be required. A similar
increase in AUC was observed in patients With moderate to severe heart failure.
Pharmacodynamics: Hemodynamics following administration of therapeutic
doses to patients with hypertension, Regcor produces vascxlilation resulting in a
reduction of supine and standing blood pressures.
These decreases in blood pressure are not accompanied b a significant change
in heart rate or plasma catecholamine levels with chronicdosing. Although the
acute intravenous administration of amlodipjne decreases arterial blood pressure
and increases heart rate in hemodynamic studies of patients with chronic stable
angina, chronic administration of oral amlodipine in clinical trials did not lead to
clinically. significant changes in heart rate or blood pressUres in normotensive
patients with angina.
With chronic once daily oral administration, antihypertensive effectiveness is
maintained for at least 24 hours. Plasma concentrations correlate with effecf in
both young and elderly patients. The magnitude of reducüon in blood pressure
with Regcor is also correlated with the height of pretreatment elevation; thus,
individuals with moderate hypertension (diastolic pressure 105 - 114 mmHg) had
about a 50% greater response than patients with mild hypertension (diastolic
pressure 90 — 104 mmHg); Normotensive subjects experienced no clinically
Significant change in blood pressures (+1/-2 mmHg).
In hypertensive patients With normal renal function, therapeutic doses Of Regcor
resulted in a decrease in renal vascular resistance and an increase in glomerular
filtration rate and effective renal plasma flow Without change in filtration fraction
or proteinuria.
As with other calcium channel blockers, hemodynamic measurements of cardiac
function at rest and during exercise (or pacing) in patients with normal
ventricular function treated, with amlodipine have generally demonstrated a
small increase in cardiac index without significant influence on dp/dt or on left
ventricular end diastolic pressure or volume. In hemodynamic studies,
amlodipine has not been associated With a negative inotroptc effect when
administered in the therapeutic dose range to intact animals and man, even
when co-administered with beta-blockersto man. Similar findings, however, have
been observed in normals or well-compensated patients With heart failure with
agents possessing significant negative inotropic effects.
Indications And Usage:
- Hypertension:
Amlodipine besylate tablets are indicated for the treatment of hypertension. They
may be used alone or in combination With other antihypertensive agents.
- Coronary Artery Disease (CAD):
Chronic Stable Angina:
Regcor tablets are indicated for the symptomatic treatment of chronic stable
angina. Regcor tablets may be used alone or in combination with other
antianginal agents.
Vasospastic Angina (Prinzmetal's or Variant Angina):
Regcor tablets are indicated for the treatment of confirmed or suspected
vasospastic angina. Regcor tablets may be used as monotherapy or in
combination with other antianginal agents.
Angiographically Documented CAD:
In patients with recently documented COD by angiography and without heart
failure or an ejection fraction €40%, Regcor tablets are indicated to reduce the
risk of hospitalization due to angina fnd to reduce the risk of a coronary
revascularization procedure.
Contraindications:
Regcor is contraindicated in patients wi known sensitivity to amlodipine.
Warnings and Precautions:
Hypotension:
Symptomatic hypotension is possible, particularly in patients with severe aortic
stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
Increased Angina or Myocardial Infarction:
Worsening angina and acute myocardial infarction can develop after starting or
increasing the dose of Regcor, particularly in patients with severe Obstructive
coronary artery disease.
Beta-Blocker Withdrawal:
Regcor is not a beta-blocker and therefore gives no protection against the
dangers of abrupt beta-blocker Withdrawal; any such withdrawal should be by
gradual reduction of the dose of beta-blocker.
Patients with Hepatic Failure:
Because Regcor is extensively metabolized by the liver and the plasma
elimination half-life (t1/2) is 56 hours in patients with impaired hepatic function,
titrate slowly when administering Regcor to patients with severe hepatic
impairment.
Drug Interactions:
In Vitro data in human plasma indicate that amlodipine has no effect on the
protein binding of drugs tested (digoxin, phenytoin, warfarin, and indomethacin ).
- Co-administration of amlodipine With cirnetidine did not alter the pharmacokinet-
ics of amlodipine.
- Co-administration of the antacid with a single dose of amlodipine had no
significant effect on the pharmacokinetics of amlodipine.
- A single 100 mg dose of sildenafil in subjects with essential hypertension had
no effect on the pharmacokinetic parameters of amlodipine. When amlodipine
and sildenafil were used in combination, each agent independently exerted its
own blood pressure lowering effect.
- Co-administration of multiple 10 mg doses of amlodipine with 80 mg of
atorvastatin resulted in no significant change in the steady state pharmacokinetic
parameters of atorvastatin.
- Co-administration of amlodipine with digoxin did not change serum digoxin
levels or digoxin renal clearance in norm$l volunteers.
- Single and multiple 10 mg doses of a
iPine had no significant effect on the
pharmacokinetics at ethanol.
- Co-administration of amlodipine with warfarin di not change the warfarin
prothrombin response time.
Drug/laboratory Test Interactions: None known.
Pregnancy: Category C. Amlodipine has been shown to prolong both the
gestation period and the duration of labor in rats, at this dose. There are no
adequate, and well-controlled studies in pregnant women-Amlodipine should be
used during pregnancy only if the potential benefit justifies the potential risk to
fetus
Nursing Mothers: it is not known whether amlodipine is excreted in human
milk. In the absence of this information, it is recommended that nursing be
discontinued while amlodipine is administered.
Pediatric Use: The effect of amlodipine on blood pressure in patients less than 6
years of age is not known,
Geriatric Use: In general, dose selection for an Iderly patient should be
cautious, usually starting at the low end of the dosing range, reflecting the
greater frequency of decreased hepatic, renal, or Cardiac function, and of
concomitant disease or other drug therapy. Elderly patients have decreased
clearance of amlodipine With a resulting increase of AUC of approximately 40 -
60%, and a lower initial dose may be required (see DOSAGE AND ADMINISTRA-
TION).
Adverse Reactions:
The following events occurred in •z but so. of patients in controlled clinical
trials or under conditions of open trials or marketing experience where a causal
relationship is uncertain; they are listed to alert the physician to a possible
relationship:
Cardiovascular: arrhythmia (including ventricular tachycardia and atrial
fibrillation), bradycardia, chest pain, hypotension, ischemia, syncope,
tachycardia, postural dizziness, postural hypotension, xpsculitis.
Central and Peripheral Nervous System: hypoesthesa, neuropathy peripheral,
paresthesia, tremor, vertigo.
Gastrointestinal: anorexia, constipation, dyspepsia, dysphagia, diarrhea,
flatulence, pancreatitis, vomiting, gingival hyperplasia.
General: allergic reaction, asthenia, back pain, hot fluShes, malaise, pain, rigors,
weight gain, weight decrease.
Musculoskeletal System: arthralgia, arthrosis, muscle cramps, myaigia.
Psychiatric: sexual dysfunction (male and female), insomnia, nervousness,
depression. abnormal dreams, anxiety, depersonalization.
Respiratory System: dyspnea, epistaxis.
Skin and Appendages: angioedema, erythema multiforme, pruritus, rash, rash
erythematous, rash maculopapular.
Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus.
Urinary System: micturition frequency, micturition disorder, nocturia.
Autonomic Nervous System: dry mouth, sweating increased.
Metabolic and Nutritional: hyperglycemia, thirst.
Hemopoietic: leukopenia, purpura, thrombocytopenia.
These events occurred in less than 1% in placebo-controlled trials, but the
incidence of these side effects was between 1% and 2% in all multiple dose
studies.
The following events occurred in of patients: cardiac failure, pulse
irregularity, extrasystoles, skin discoloration, urticaria, skin dryness, alopecia,
dermatitis, muscle weakness, twitching, ataxia, hypertonia, migraine, cold and
clammy skin, apathy, agitation, amnesia, gastritis, increased appetite, loose stools,
coughing, rhinitis, dysuria. polyuria, parosmia, taste perversion, abnormal visual
accommodation, and xerophthalmia.
Other reactions occurred sporadically and cannot be distinguished from
medications or concurrent disease states such as myocardial infarction and
angina.
Arnlodipjne therapy has not been associated with clinically significant changes in
routine laboratory tests. No clinically relevant changes were noted in serum
potassium, serum glucose, total triglycerides, total cholesterol, HDL cholesterol,
uric acid, blood urea nitrogen, or creatinine,
Postmarketing Experience:
Because these reactions are reported voluntarily from a population of uncertain
size, it is not always possible to reliably estimate thei( frequency or establish a
causal relationship to drug exposure,
The following postmarketing event has been reported infrequently where a
causal relationship is uncertain: gynecomastia. In postmarketing experience,
jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or
hepatitis), in some cases severe enough to require hospitalization, have been
reported in association with use of amlodipine.
Amlodipine has been used safely in patients with chronic obstructive pulmonary
disease, well-compensated congestive heart failure, coronary artery disease,
peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.
Overdosage: 
Single oral doses of 40 mg/kg and 100 mg/kg in mice nd rats, respectively, 
s caused a marked 
caused deaths. A single oral dose of 4 mg/kg or higher in 
peripheral vasodilatation and hypotension. 
Overdosage might be expected to cause excessive peripheral vasodilatation with 
marked hypotension and possibly a reflex tachycardia. Inl humans, experience 
with intentional over dosage of Regcor is limited: Reports of intentional 
overdosage include a patient who ingested 250 mg and was asymptomatic and 
was not hospitalized; another (120 mg) was hospitalized, underwent gastric 
lavage and remained normotensive; the third (105 mg) washospitalized and had 
hypotension (90/50 mmHg) which normalized following blasma expansion. A 
patient who took 70 mg amlodipine and an unknown quantity of benzodiazepine 
in a suicide attempt developed shock which was refractory to treatment and died 
the following day with.abnorrnally high benzodiazepine plasma concentration, A 
case of accidental drug overdose has been documented in 19 month-old male 
who ingested 30 mg amlodlpine (about 2 mg/kg). 
During the emergency room presentation, vital signs ere stable with no 
evidence of hypotension, but a heart rate of 180 bpm. Ipecac was administered 
3.5 hours after ingestion and on subsequent observation (ovemight) no sequelae 
were noted. 
If massive overdose should occur, active cardiac and respiratory monitoring 
should be instituted. Frequent blood pressure measurements are essential. 
Should hypotension occur, cardiovascular support including elevation of the 
extremities and the judicious administration of fluids should be initiated. If 
hypotension remains unresponsive to these conservative measures. administra- 
tion of vasopressors (such as phenylephrine) should be conSidered with attention 
to circulating volume and urine output. Intravenous calcium gluconate may help 
to reverse the effects of calcium entry blockade. As Regcor is highly protein 
bound, hemodialysis is not likely to be of benefit. 
Dosage And Administration: 
Adults: The usual initial antihypertensive oral dose of Regcor is 5 mg once daily 
with a maximum dose of 10 mg once daily. Small, fragile, or elderly individuals, 
or patients with hepatic insufficiency may be started on 2.5 mg once daily and 
this dose may be used when adding Regcor to other antihypertensive therapy. 
In general, titration 
Dosage should be adjusted according to each patient's n 
should proceed over 7 to 14 days so that the physician can fully assess the 
patient's response to each dose level. Titration may proceed more rapidly, 
however, if clinically warranted, provided the patient is assessed frequently. 
The recommended dose for chronic stable or vasospastic angina is 5-10 mg, with 
the lower dose suggested in the elderly and in patients with hepatic insufficiency. 
Most patients will require 10 mg for adequate effect. See ADVRSE REACTIONS 
section for Information related to dosage and side effects. 
Children: The effective antihypertensive oral dose in pediatric patients ages 6-17 
years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been 
studied in pediatric patients. See CLINICAL PHARMACOLOGY. 
Coadministration with other antihypertensive and/or Antianginal drugs: 
Regcor has been safely administered with thiazides, ACE inhibitiors, beta- 
blockers, long-acting nitrates, and/or sublingual nitroglycerin. 
Storage: 
Store in a dry place at temperature not exceeding 300C. 
Keep out of reach of children. 
How supplied: 
Regcor 5 mg Tablets: Carton box containing I (AL/PVC) strip of 10 tablets and 
an inner leaflet. 
Regcor 10 mg Tablets: Carton box containing 1 (AL/PVC) ytrip of 10 tablets and 
an inner leaflet. 
Date of revision: 
December 2010. 
This is a Medicament. 
•Medicarnent is a prodiEt which affects your health, aru its consumptbn antrary to instr'Ætions 
is dangerous for you. 
•Folbw strictb•y the doctor's tie method of use, instrudkns of the pharmacist 
who sold nEdicament. 
•The doctor and the pharmacist are in me"v, its benefits arri risks. 
•Do not intermpt the period treatment prescrbed by yourself. 
•Do rwt repeat the same prescription without consulting ywr 
•Keep rnedcires out 0t the reach Of Olikiren, 
56 g/m2 11B 500 PAM 001 
PMS: Black C. 17 X 21 CM 
EEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE 
EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO. 
E. 1. P. 1. CO. 
10th OF RAMADAN CITY , INDUSTRIAL AREA Bl, P.o. BOX: TENTH, EGYPr 

PROXIMOL COMPOUND

PROXIMOL COMPOUND
PROXIMOL COMPOUND Effervescent granules
For expulsion of ureteric stones - Uric acid dissolvent - Urinary antiseptic.
Composition :
Each 100 gm contains
Halfa bar extract
Equivalent to 8 mg Proximadiol
Hexamine
Piperazine citrate
Properties :
18.6 mg
6 gm
1 gm
PROXIMOL COMPOUND acts as an efficient preparation for expulsion of
ureteric calculi by the unique action of its content of proximadiol (present in the
purified extract of Halfa bar) which produces ureteric dilatation while increasing
the propulsive movement of the smooth muscles of the ureter, helping the
expulsion of the calculi.
PROXIMOL COMPOUND also dissolves uric acid and urate crystals prevents
their deposition in the urinary tract, and these effects are mainly achieved by the
action of Piperazine citrate,
In addition to the fore-mentioned properties, PROXIMOL COMPOUND acts as
an effective urinary antiseptic due to its content of Hexamine which liberates
formaldehyde in the urine. Formaldehyde possesses antibacterial activity
against many bacteria responsible for urinary tract infections.
Indications :
-As propulsive for ureteric stones.
- Presence of excess uric acid and urate crystals in urine.
- Urinary tract infections e.g. pyelitis, cystitis, urethritis.
Side effects :
Rarely nausea may occur.
Contraindications :
- Hypersensitivity to any of the components.
- Impairment of renal or hepatic function,
Use in Pregnancy
During pregnancy its safety has not been justified , so it is better to be avoided
during the first trimester as many other new drugs.
Precautions :
Some of the rarely used sulphonamides,e.g sulphamethizole and sulpathiazole,
may form insoluble precipitate with the liberated formaldehyde in the urine,so,
hexamine containing preparations are not recommended to be used concurrently
with these sulphonamides.
Dosage :
2 teaspoonfuls (or 1 sachet) in 1/2 glass of water three times daily after meals
as directed by physician.
Caution :
To be used only under medical supervision.
Notice :
Patients with urinary lithiasis should be advised to intake plenty of fluids to
help extrusion of the calculi.
Packing :
- sealed glass bottles of 60 gm.
- Sachets of 5 gm. (Boxes of 12 sachets).
Storage :
Store below 250C, protected from humidity.
produced by
KAHIRA PHARM. & CHEM. IND. CO.
CAIRO - EGYPT
Ps.78

Oxybin

Oxybin 

EIPICO
For For The Medical Profession Only
Oxybin
Tablets - Syrup (5 ml)
5 mg
Composition:
Each dosage unit contains:
Oxybutynin hydrochloride
Inactive ingredient:
Tablet
5 mg
Tablets: Microcrystalline Cellulose, Maize starch, sodium starch glycolate. magnesium
stearate, lactose monohydrate. aerosil 200.
Syrup: Citric acid anhydrous. sodium citrate anhydrous, sucrose, sorbitol 70 %
solution, methyl paraben, sucralose, sodium cyclamate, glycerol, purified water.
Therapeutic Indications:
Oxybin is indicated for urinary incontinence, urgency and frequency in unstable
bladder conditions due either to idiopathic detrusor instability or neurogenic
bladder disorders (detrusor hyperreflexia) in conditions such as spina bifida and
multiple sclerosis.
In addition, for children over 5 years of age, oxybutynin may be used in nocturnal
enuresis in conjunction with non-drug therapy where this alone, or in conjunction
with other drug treatment, has failed.
Posology and Method of Administration:
Adults: The usual dose is 5 mg two or three times a day. This may be increased to
a maximum dosage of 5 mg four times a day (20 mg) to obtain a satisfactory
clinical response provided that the side effects are tolerated.
Children under 5 years of age: Not recommended.
Children over 5 years of age:
Neurogenic bladder disorders: The usual dose js 5 mg twice a day. This may be
increased to a maximum of 5 mg three times a day to obtain a clinical response
provided that the side effects are tolerated.
Nocturnal enuresis: The usual dose is 5 mg two or three times a day. The last dose
should be given before bedtime.
In children, the maintenance dose may be achieved by upward titration from an
initial dose of 2.5 mg twice daily.
Elderly: The elimination half-life may be increased in some elderly patients,
therefore, dosage should be individually titrated commencing at 2.5 mg 2-3 times
a day. The final dosage will depend on response and tolerance to side effects. As
with other anticholinergic drugs caution should be observed in frail and elderly
patients.
Contraindications:
- Hypersensitivity to oxybutynin or to any component.
- Myasthenia gravis.
- Narrow-angle glaucoma or shallow anterior chamber.
- Gastrointestinal obstruction including paralytic ileus or intestinal atony.
- Patients With toxic megacolon, severe ulcerative colitis.
- Patients with bladder outflow obstruction, where urinary retention may be precipitated.
Special warnings and precautions for use:
Oxybutynin should be used with caution in the frail elderly and children who may be
neuropathy, hepatic or renal impairment or severe gastrointestinal motility disorders.
Oxybutynin may aggravate the symptoms of hyperthyroidisrn, congestive heart
failure, coronary heart disease, cardiac arrhythmia, tachycardia, hypertension and
prostatic hypertrophy
Oxybutynin can cause decreased sweating; in high environmental temperatures
this can lead to heat prostration.
The use of oxybutynin in children under 5 years of age is not recommended; it has
not been established whether oxybutynin can be safely used in this age group.
Special care should be taken in patients with hiatus hernia associated with reflux
oesophagitis, as anticholinergic drugs can aggravate this condition.
Lactose: The tablets contain lactose monohydrate. Patients with rare hereditary
problems of galactose intolerance, the Lapp deficiency or glucose-galactose
malabsorption should not receive this medicine.
Interaction with other medicinal products:
Care should be taken if other anticholinergic agents are administered together
With Oxybin, as potentiation of anticholinergic effects could occur.
Occasional cases of interaction between anticholinergics and clozapine, phenothiaz-
ines, amantidine, butyrophenones, L-dopa, digitalis and tricycllc antidepressants have
been reported and care should be taken if Oxybin is administered concurrently With
such drugs.
By reducing gastric motility, oxybutynin may affect absorption of other drugs.
Pregnahcy and lactation:
There is no experience of the use of oxybutynin during pregnancy in humans,
however, in foetal toxicity and fertility studies in animals. effects were seen on
reproductive processes at dosages associated with maternal toxicity. Oxybin
should, therefore, only be prescribed during pregnancy if considered essential.
Lactation:
Small amounts of oxybutynin have been found in mother's milk of lactating
animals. Breast-feeding while using Oxybin is therefore not recommended.
Effects on ability to drive and to use machines:
As Oxybin may produce drowsiness or blurred vision, the patient should be
cautioned regarding activities requiring mental alertness such as driving,
operating machinery or performing hazardous work while taking this drug.
Undesirable effects:
Gastrointestinal disorders:
Nausea, diarrhoea, constipation, dry mouth, abdominal discomfort, anorexia, vomiting,
gastroesophageal reflux
CNS and psychiatric disorders:
Agitation, headache, dizziness, drowsiness, disorientation, hallucinations, nightmares,
convulsions.
Cardiovascular disorders:
Tachycardia, cardiac arrythmia.
Vision disorders:
Blurred vision, mydriasis, intraocular hypertension, onset of narrow-angle glaucoma,
dry eyes.
Renal and urinary disorders:
Urinary retention, difficulty in micturition.
Skin and appendages:
Facial flushing which may be more marked in children, dry skin, allergic reactions
such as rash, urticaria, angioedema, photosensitivity.
Overdose:
The symptoms of overdosage with oxybutynin progress from an intensification of
the usual side effects of CNS disturbances (from restlessness and excitement to
psychotic behaviour), circulatory changes (flushing, fall in blood pressure,
circulatory failure .. etc.), respiratory failure, paralysis and coma.
Measures to be taken are:
1- Immediate gastric lavage.
2- physostigmine by slow intravenous injection.
Adults: 0.5 to 2.0 mg of physostigmine by slow intravenous administration.
Repeat after 5 minutes, if necessary, up to a maximum total dose of 5 mg.
Children: 30 micrograms/kg of physostigmine by slow Intravenous administration.
Repeat after 5 minutes, if necessary, up to a maximum total dose of 2 mg.
Fever should be treated symptomatically with tepid sponging or ice packs.
In pronounced restlessness or excitation, diazepam 10 mg may be given by
intravenous injection. Tachycardia may be treated with intravenous propanolol
and urinary retention managed by bladder catheterization.
In the event of progression of the curare-like effect to paralysis of the respiratory
muscles, mechanical ventilation Will be required.
Pharmacological properties:
Pharmacodynamic properties:
Oxybutynin hydrochloride is an anticholinergjc agent which also exerts a direct
antispasmodic effect on smooth muscle. It inhibits bladder contraction and relieves spasm
induced by various stimuli; it increases bladder volume, diminishes the frequency of
contractions and delays the desire to avoid in the disturbance of neurogenic bladder. The
relaxation of smooth muscle results from the papaverine- like effect of the antagonism of
the processes distal to the neuromuscular junction in addition to the anticholinergic
blocking action of the muscarinic type receptors. In addition, oxybutynin hydrochloride
has local anaesthetic properties.
Pharmacokinetic properties:
Oxybutynin is rapidly absorbed from the gastrointestinal tract following oral
administration with maximum plasma concentrations reached in less than I hour
subsequently falling bioexponentially with a half-life of between 2 and 3 hours.
Maximum effect can be seen within 3-4 hours with some effect still evident after
10 hours.
Repeated oral administration achieved steady state after eight days. Oxybutynin
does not appear to accumulate in elderly patients and the pharmacokinetics are
similar to those in other adults. Some excretion via the biliary system has been
observed in the rabbit and partial first-pass metabolism occurred; the metabolites
also appearing to have antimuscarinic properties. The main elimination route is
via the kidneys with only 0.3 - 0.4% of unchanged drug appearing in the urine of
the rat after 24 hours and 1% appearing in the urine of the dog after 48 hours. In
rats and dogs therefore, oxybutynin appears to be almost completely absorbed.
Storage:
Tablets: Store in a dry place at a temperature not exceeding 30T.
Syrup: Store at a temperature not exceeding 30•C.
Packaging:
Oxybin Tablets: Carton box containing 2 strips (AL/PVC) of 10 scored tablets each
and insert leaflet.
Oxybin Syrup: Carton box containing an amber glass bottle of 120 ml with pilfer-
proof aluminum cap and insert leaflet.
Date of revision:
january 2014.
This is a Medicament.
•Medicament is a prodtrt which affects your and its consumption contrary to instructbns
is for
•Follow strictly the doctor's prescription, thE method of use, and the instructions of the pharrnacist
wt•w wkl the
•The are experts in its benefits and risks.
•Do mt interrupt the period of treatrnent prescribed by yourser.
•Do repeat sarne prescr$tbn wittout consulting your
•Keep out ot reach ot chMren.
issue date:june2014 PMS: Black C. 17 X 21 CM 56gh-n2 110 100 PAM 000001
EEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE
EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.
10th OF RAMADAN CITY, INDUSTRIAL AREA Bl, P.o. BOX: 149 TENTH, EGYPr

Normolepsy

Normolepsy 

Normolepsy 


For The Medical Profession Only 
Normolepsy 
Capsules 
Composition: 
Each capsule contains: 
Pregabalin . 
30 - 60 
15 -K 30 
EIPICO 
. 75, 150 mg 
Excipients: microcrystalline cellulose, maize starch, purified talc. 
Therapeutic Indications: 
Neuropathic pain: Normolepsy is indicated for the treatment of peripheral and 
central neuropathic pain in adults. 
Epilepsy: Normolepsy is indicated as adjunctive therapy in adults with partial 
seizures with or without secondary generalisation. 
Generalised Anxiety Disorder: Normolepsy is indicated for the treatment of 
Generalised Anxiety Disorder (GAD) in adults. 
Posology and Method of Administration: 
Posology: 
The dose range is 150 to 600 mg per day given in either two or three divided doses. 
Neuropathic pain: Normolepsy treatment can be started at a dose of 150 mg per 
day given as two or three divided doses. Based on individual patient response and 
tolerability, the dose may be increased to 300 mg per day after an interval of 3 to 
7 days, and if needed, to a maximum dose of 600 mg per day after an additional 
7-day interval. 
Epilepsy: Normolepsy treatment can be started With a dose of 150 mg per day 
given as two or three divided doses. Based on individual patient response and 
tolerability, the dose may be increased to 300 mg per day after I week The maximum 
dose of 600 mg per day may be achieved after an additional week. 
Generalised Anxiety Disorder: The dose range is 150 to 600 mg per day given as 
two or three divided doses. The need for treatment should be reassessed regularly. 
Normolepsy treatment can be started with a dose of 150 mg per day. Based on 
individual patient response and tolerability, the dose may be increased to 300 mg 
per day after 1 week. Following an additional week the dose may be increased to 
450 mg per day. The maximum dose of 600 mg per day may be achieved after an 
additional week. 
Discontinuation of Normolepsy : In accordance with current clinical practice, if 
Normolepsy has to be discontinued, it is recommended this should be done 
gradually over a minimum of I week independent of the indication. 
Special populations: 
Patients with renal impairment: Pregabalin is eliminated from the systemiC 
circulation primarily by renal excretion as unchanged drug. As pregabalin 
clearance is directly proportional to creatinine clearance, dose reduction in patients 
with compromised renal function must be individualised according to creatinine 
clearance (CLcr), as indicated in Table 1 determined using the following formula: 
((140-age (years)) X weight (kg) 
(X 0.85 for women) 
CLcr (ml/min)— 
72 x serum creatinine (mg/dl) 
Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). 
For patients receiving haemodialysis, the Normolepsy daily dose should be adjusted 
based on renal function. In addition to the daily dose, a supplementary dose should be 
given immediately following every 4-hour haemodialysis treatment (see Table 1). 
Table 1. Normolepsy dose adjustment based on renal function 
Creatinine clearance 
(CLcr) (mL/min) 
60 
c: 15 
Total Normolepsy 
daily dose* 
Starting dose Maximum dose 
Dose regimen 
BID or TID 
BID or TID 
Once Daily or BID 
Once Daily 
Single dose* 
(mg/ day) 
150 
75 
25 - 50 
25 
(mg/ day) 
600 
300 
150 
75 
Supplementary dosage following haemodialysis (mg) 
25 
100 
TID Three divided oses. 
BID Two divided doses. 
- Total daily dose mg/day) should be divided as indicated by dose regimen to 
provide mg/dose. 
- Supplementary dbse is a single additional dose. 
Use in patients with hepatic impairment: No dose adjustment is required for 
patients with hepatic impairment. 
Paediatric population: The safety and efficacy of Normolepsy in children below 
the age of 12 years and in adolescents (12-17 years of age) have not been 
established. No data is available. 
Use in the elderly/ (over 65 years of age): Elderly patients may require a dose 
reduction Of Normolepsy due to a decreased renal function (see patients with 
renal impairment). 
Method of administration: 
Normolepsy may be taken with or without food. 
Normolepsy is for oral use only. 
Contraindications: 
Hypersensitivity to the active substance or to any of the excipients. 
Special warnings and precautions for use: 
Diabetic patients: 
In accordance with current clinical practice, some diabetic patients who gain weight 
on Normolepsy treatment may need to adjust hypoglycaemjc medicinal products. 
Hypersensitivity reactions: 
There have been reports in the post-marketing experience of hypersensitivity reactions, 
including cases of angioedema. Normolepsy should be discontinued immediately if 
symptoms of angioedema, such as facial, peri-oral, or upper airway swelling occur. 
Dizziness, somnolence, loss of consciousness, confusion, and mental impairment: 
Normolepsy treat1T1ent has been associated with dizziness and somnolence, which 
could increase the occurrence of accidental injury (fall) in the elderly population. 
There have also been post-marketing reports of loss of consciousness, confusion 
and mental impairtnent. Therefore, patients should be advised to exercise caution 
until they are familiar with the potential effects of the medicinal product. 
Vision-related effects: 
Patients treated with pregabalin reported blurred Vision, visual acuity reduction, 
visual field changeS and fundoscopic changes. 
In the post-marketing experience, visual adverse reactions have also been reported, 
including loss of vision, visual blurring or other changes of visual acuity, many of 
which were transient. Discontinuation Of Normolepsy may result in resolution or 
improvement of th visual symptoms. 
Renal failure: 
Cases of renal failure have been reported and in some cases discontinUation of 
pregabalin did show reversibility of this adverse reaction. 
Withdrawal of concomitant antiepileptic medicinal products: 
There are insufficient data for the withdrawal of concomitant antiepileptic 
medicinal products, once seizure control with pregabalin in the add-on situation 
has been reached, in order to reach monotherapy on pregabalin. 
Withdrawal symptoms: 
After discontinuation of short-term and long-term treatment with pregabalin 
withdrawal symptoms have been observed in some patients. The following events 
have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu 
syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and 
dizzinessl The patient should be informed about this at the start of the treatment 
With Normolepsy. 
Convulsions, including status epilepticus and grand mal convulsions, may occur 
during Normolepsy use or shortly after discontinuing Normolepsy. 
Concerning discontinuation of long-term treatment of Normolepsy, there are no 
data of the incidence and severity of withdrawal symptoms in relation to duration 
of use and dose of:pregabalin. 
Congestive heart failure: 
There have been 'post-marketing reports of congestive heart failure ih some 
patients receiving pregabalin. These reactions are mostly seen in elderly 
cardiovascular compromised patients during pregabalin treatment for a 
neuropathic indication. Normolepsy should be used with caution in these 
patients. Discontinuation of Normolepsy may resolve the reaction. 
Treatment of central neuropathic pain due to spinal cord injury: 
In the treatment of central neuropathic pain due to spinal cord injury the incidence of 
adverse reactions in general, central nervous system adverse reactions and especially 
somnolence was increased. This may be attributed to an additive effect due to 
concomitant medicinal products (e.g. anti-spasticity agents) needed for this condition. 
This should be considered when prescribing Normolepsy in this condition. 
Suicidal ideation and behaviour: 
Suicidal ideation and behaviour have been reported in patients treated with 
anti-epileptic agents in several indications. A meta-analysis of randomised placebo 
controlled studies of anti-epileptic drugs has also shown a small increased risk of 
suicidal ideation and behaviour. The mechanism of this risk is not known and the 
available data do not exclude the possibility of an increased risk for pregabalin. 
Therefore patients should be monitored for signs of suicidal ideation and 
behaviours and appropriate treatment should be considered. Patients (and 
caregivers of patients) should be advised to seek medical advice if signs of suicidal 
ideation or behaviour emerge. 
Reduced lower gastrointestinal tract function: 
There are post-marketing reports of events related to reduced lower gastrointesti- 
nal tract function (e.g. intestinal obstruction, paralytic ileus, constipation) when 
pregabalin was co-administered With medications that have the potential to 
produce constipation, such as opioid analgesics. When Normolepsy and opioids 
will be used in combination, measures to prevent constipation may be considered 
(especially in female patients and elderly). 
Abuse potential: 
Cases Of abuse have been reported. Caution should be exercised in patients with a 
history of substance abuse and the patient should be monitored for symptoms of 
Normolepsy abuse. 
Encephalopathy: 
Cases of encephalopathy have been reported, mostly in patients with underlying 
conditions that may precipitate encephalopathy. 
Interaction with other medicinal products: 
Since Normolepsy is predominantly excreted unchanged in the urine, undergoes 
negligible metabolism in humans («2% of a dose recovered in urine as 
metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma 
proteins, it is unlikely to produce, or be subject to, pharrnacokinetic interactions. 
In vivo studies and population pharmacokinetic analysis: 
Accordingly, In in vivo studies, no clinically relevant pharmacokinetic interactions 
were observed between pregabalin and phenyt0in, carbamazepine, valprojc acid, 
Iamotrigine, gabapentin, lorazepam, oxycodone or ethanol. Population 
pharmacokinetic analysis indicated that oral antidiabetics, diuretics, insulin, 
phenobarbital, tiagabine and topiramate had no clinically significant effect on 
pregabalin clearance. 
Oral contraceptives, norethisterone and/or ethinyl oestradiol: 
Co-administration of Normolepsy With the oral contraceptives norethisterone 
and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of 
either substance. 
Ethanol, lorazepam, oxycodone: 
Normolepsy may potentiate the effects of ethanol and lorazepam. 
Co-administeration with oxycodone, lorazepam, or ethanol did not result in 
clinically important effects on respiration. In the post-marketing experience, there 
are reports of respiratory failure and coma in patients taking pregabalin and other 
CNS-depressant medicinal products. Normolepsy appears to be additive in the 
impairment of cognitive and gross motor function caused by oxycodone. 
Interactions and the elderly: 
No specific pharmacodynamic interaction studies were conducted in elderly 
volunteers. Interaction studies have only been performed in adults. 
Fertility, Pregnancy and Lactation: 
Women of childbearing potential / Contraception in males and females: 
As the potential risk for humans is unknown, effective contraception must be used 
in women of child bearing potential. 
Pregnancy: 
There are no adequate data from the use of pregabalin in pregnant women. 
Normolepsy should not be used during pregnancy unless clearly necessary (if the 
benefit to the mother clearly outweighs the potential risk to the foetus). 
Breast-feeding: 
It is not known if pregabalin is excreted in the breast milk of humans; however, it 
is present in the milk of rats. Therefore, breast-feeding is not recommended during 
treatment with Normolepsy. 
Fertility: 
There are no clinical data on the effects of pregabalin on female fertility. 
Pregabalin has no effects on sperm motility. 
Effects on ability to drive and to use machines: 
Normolepsy may have minor or moderate influence on the ability to drive and use 
of machines. Normolepsy may cause dizziness and somnolence and therefore 

may influence the ability to drive or to use machines. Patients are advised not to
drive, operate complex machinery or engage in other potentially hazardous
activities until it is known whether this medicinal product affects their ability to
perform these activities.
Undesirable effects:
The most commonly reported adverse reactions are dizziness and somnolence.
Adverse reactions were usually mild to moderate in intensity. The most common
adverse reactions resulting in discontinuation from pregabalin treatment groups
were dizziness and somnolence.
The following adverse reactions are listed by class and frequency (very common (2
1/10); common (2 1/100 to •€1/ 10); uncommon (2 1/1,000 to «I/IOO); rare (2
1/10,000 to «I/I,OOO); very rare («1/10,000), not known (cannot be estimated
from the available data).
Within each frequency grouping, undesirable effects are presented in order of
decreasing seriousness.
The adverse reactions listed may also be associated with the underlying disease
and / or concomitant medicinal products.
In the treatment of central neuropathic pain due to spinal cord injury the incidence
of adverse reactions in general, CNS adverse reactions and especially somnolence
was increased.
Additional reactions reported from post-marketing experience are included as
"Frequency not known" in the list below.
Infections and infestations:
Uncommon: Nasopharyngitis.
Blood and lymphatic system disorders:
Rare: Neutropenia.
Immune system disorders:
Frequency not known: Hypersensitivity, angioedema, allergic reaction.
Metabolism and nutrition disorders:
Common: Increased appetite.
Uncommon: Anorexia, hypoglycaemia.
Psychiatric disorders:
Common: Euphoric mood, confusion, irritability, decreased libido, disorientation, insomnia.
Uncommon: Hallucination, panic attack, restlessness, agitation, depression, depressed
mood, mood swings, depersonalisation, word finding difficulty, abnormal dreams,
increased libido, anorgasmia, apathy.
Rare: Disinhibition, elevated mood.
Frequency not known: Aggression
Nervous system disorders:
Very Common: Dizziness, somnolence.
Common: Ataxia, coordination abnormal, tremor, dysarthria, memory impairment,
disturbance in attention, paraesthesia, sedation, balance disorder, lethargy, headache.
Uncommon: Syncope, stupor, myoclonus, psychomotor hyperactivity, ageusia,
dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, speech
disorder, hyporeflexia, hypoaesthesia, amnesia, hyperaesthesia, burning sensation.
Rare: Hypokinesia, parosmia, dysgraphia.
Frequency not known: Loss of consciousness, mental impairment, convulsions, malaise.
Eye disorders:
Common: Vision blurred, diplopia.
Uncommon: Visual disturbance, eye swelling, visual field defect, visual acuity
reduced, eye pain, asthenopia, dry eye, increased lacrimation.
Rare: Peripheral vision loss, oscillopsiä, altered visual depth perception, photopsia,
eye irritation, mydriasis, strabismus, visual brightness.
Frequency not known: Vision loss , keratitis.
Ear and labyrinth disorders:
Common: Vertigo.
Uncommon: Hyperacusis.
Cardiac disorders:
Uncommon: Tachycardia, atrioventricular first degree block.
Rare: Sinus tachycardia, sinus bradycardia, sinus arrhythmia.
'Frequency not known: Congestive heart failure, QT prolongation.
Vascular disorders:
Uncommon: Flushing, hot flushes, hypotension, hypertension.
Rare: Peripheral coldness.
Respiratory, thoracic and mediastinal disorders:
Uncommon: Dyspnoea, nasal dryness.
Rare: Epjstaxis, throat tightness, cough, nasal congestion, rhinitis, snoring.
Frequency not known: Pulmonary oedema.
Gastrointestinal disorders:
Common: Vomiting, dry mouth, constipation, flatulence.
Uncommon: Abdominal distension, gastro-oesophageal reflux disease, salivary
hypersecretion, oral hypoaesthesia
Rare: Ascites, pancreatitis, dysphagia.
Frequency not known: Swollen tongue, diarrhoea, nausea.
Skin and subcutaneous tissue disorders:
Uncommon: Papular rash, hyperhidrosis.
Rare: Urticaria, cold sweat.
Frequency not known: Stevens Johnson syndrome, pruritus.
Musculoskeletal and connective tissue disorders:
Uncommon: Muscle twitching, joint swelling, muscle cramp, myalgia, arthralgia,
back pain, pain in limb, muscle stiffness.
Rare: Rhabdomyolysis, cervical spasm, neck pain.
Renal and urinary disorders:
Uncommon: Urinary incontinence! dysuria.
Rare: Renal failure, oliguria.
Frequency not known: Urinary retention.
Reproductive system and breast disorders:
Common: Erectile dysfunction.
Uncommon: Delayed ejaculation, sexual dysfunction.
Rare: Amenorrhoea, breast discharge, breast pain, dysmenorrhoea, breast hypertrophy.
General disorders and administration site conditions:
Common: Abnormal gait, feeling drunk, fatigue, peripherål oedema, oedema.
Uncommon: Fall, chest tightness, asthenia, thirst, pain, feeling abnormal, chills.
Rare: Generalised oedema, pyrexia.
Frequency not known: Face oedema.
Investigations:
Common: Increased weight.
Uncommon: Increased blood creatine phosphokinase, increased alanine aminotrans-
ferase, increased aspartate aminotransferase, decreased platelet count.
Rare: Increased blood glucose, decreased blood potassium, decreased white blood
cell count, increased blood creatinine, decreased weight.
After discontinuation of short-term and long-term treatment With pregabalin
Withdrawal symptoms have been observed in some patients. The following reactions
have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu
syndrome, convulsions, nervousness, depression, pain, hyperhidrosis and dizziness.
The patient should be informed about this at the start of the treatment.
Concerning discontinuation of long-term treatment of pregabalin, there are no
data of the incidence and severity of withdrawal symptoms in relation duration
of use and dose of pregabalim
Overdose:
In overdose up to 15 g, no unex ed adverse reaction were reported.
In the post-marketing experience,'the most commonly reported adverse reactions
observed when pregabalin was taken in overdose included somnOIence,
confusional state, agitation, and restlessness.
Treatment of pregabalin overdose should include general supportive measures
and may include haemodialysis if necessary (see Table I).
Pharmacological Properties:
Pharmacodynamic properties:
Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics.
The active substance, pregabalin, is a gamma-aminobutyric acid analogue
((S)-3-(aminomethyI)-5-methylhexanoic acid).
Mechanism of action:
Pregabalin binds to an auxiliary subunit (C12-n protein) of voltage-gated calcium
channels in the central nervous system,
Pharmacokinetic properties:
Pregabalin steady-state pharmacokinetics are similar in healthy volunteers,
patients with epilepsy receiving anti-epileptic drugs and patients with
chronic pain.
Absorption:
Pregabalin is rapidly absorbed when administered in the fasted state, With peak
plasma concentrations occurring Within I hour following both single and multiple
dose administration. Pregabalin oral bioavailability is estimated to be 9096 and is
independent of dose. Following repeated administration, steady state is achieved
within 24 to 48 hours. The rate of pregabalin absorption is decreased when given
with food resulting in a decrease in Cmax by approximately 25-30% and a delay in
tmax to approximately 2.5 hours. However, administration Of pregabaltn With food
has no clinically significant effect on the extent of pregabalin absorption.
Distribution:
In humans, the apparent volume of distribution of pregabalin following oral
administration is approximately 0.56 1/kg. Pregabalin is not bound to plasma
proteins.

Nanazoxid

Nanazoxid 


Nanazoxid 
Nitazoxanide 500mg 
Intestinal Antiprotozoal Film coated tablets 
Company Name: Pharmed Healthcare for Utopia Pharmaceuticals. Composition: Each film coated tablet contains: Active Ingredients: Nitazoxanide 500mg. Inactive Ingredients: Povidone k 30, Microcristalline cellulose (Avicel PH 101),Croscarmellose sodium,Sodium starch glycolate,Colloidal silicon dioxide,Talc , Magnesium stearate ,Hydroxypropyl methylcellulose E15,PEG 6000,Titanium dioxide, Tween 80, Yellow ferric oxide. Description: Nanazoxid 500mg tablets contains the active ingredient nitazoxanide; a synthetic antiprotozoal agent for oral administration. Chemically, nitazoxanide is 2-acetyloxy-N-(5-nitro-2-thiazolyl) benzamide. The structural formula is: 
Clinical Pharmacology: Absorption: Following oral administration of Nanazoxid 500mg tablets, maximum plasma concentrations of the active metabolites tizoxanide and tizoxanide glucuronide are observed within 1-4 hours. The parent nitazoxanide is not detected in plasma. When Nanazoxid 500mg tablet was administered with food, the AUC, of tizoxanide and tizoxanide glucuronide increased almost two-folds and the Cmax increased by almost 50%. Distribution: In plasma, more than 99% of tizoxanide is bound to proteins. Metabolism: Nitazoxanide is rapidly hydrolyzed to an active metabolite, tizoxanide (desacetyl-nitazoxanide). Tizoxanide then undergoes conjugation, primarily by glucuronidation. Elimination: Tizoxanide is excreted in the urine, bile and feces, and tizoxanide glucuronide is excreted in urine and bile. Approximately two-thirds of the oral dose of nitazoxanide is excreted in the feces and one-third in the urine. Mechanism of Action: The antiprotozoal activity of nitazoxanide is believed to be due to interference with the pyruvate ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction which is essential to anaerobic energy metabolism. Indications and Usage: Nanazoxid 500mg tablets is indicated for the treatment of diarrhea caused by giardia lamblia or cryptosporidium parvum. Dosage and Administration: One tablet every 12 hours with food for three days. Overdosage: Information on nitazoxanide overdosage is not available. Contraindications: Nanazoxid 500gm tablets is contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulation. Adverse Reactions: The most frequent adverse events reported were: Abdominal pain, diarrhea, vomiting and headache. Drug Interactions: Tizoxanide is highly bound to plasma protein (>99.9%). Therefore, caution should be used when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g. Warfarin.) Pregnancy and Lactation: No adequate and well-controlled studies are available in pregnant women. It is not known whether nitazoxanide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitazoxanide is administered to a nursing women. Precautions: Nitazoxanide must be administered with caution to patients with hepatic and bilary diseases, to patients with renal diseases, and to patients with combined renal and hepatic disease. Package: Carton box containing 1 or 3 PVDC/AL Strips; each strip 6 film coated tablets with an insert leaflet.
Storage: - Keep out of reach of children. __ _ - Keep at a temperature not exceeding 30°C in a dry place. Information for Patients: Nanazoxid 500mg tablets should be taken with food. Produced by Pharmed Healthcare for Utopia Pharmaceuticals. 



momsone

momsone
Momsone 
0.1 % cream 
Composition : 
Each gram of cream contains . 
Mometasone furoate anhydrous 
Properties : 
SEDICO 
1 mg 
Mometasone furoate is a topical synthetic corticosteroid with moderately potent - 
antiinflammatory, antipruritic and vasoconstrictive activity. 
Pharmacokinetics : 
Human studies indicates that about 0.4 - 0.7 % of the applied dose enters the 
circulation after 8 hours of contact on normal skin without occlusion dressinas . 
Indications : 
Relief of inflammatory, pruritic manifestations of corticosteroid - responsive 
dermatoses . 
Contra-indications : 
Patients with a history of hypersensitivity to corticosteroids or any of ingredients. 
Precautions : 
- Avoid risk factors that enhance its penetration and systemic absorption such as : 
use for over large surface areas, disrupted epidermal barrier or use for areas undew 
occlusive dressings. 
- If concomitant or developed skin infections, appropriate antibacterial or antifungal 
agent is used . 
- It should not be used on face, eyes, diaper areas, underarms, or groin areas 
unless directed by physician . 
- Discontinue therapy when control is achieved . 
- Pediatric patients under 2 years old due to lack ofwell- controlled studies . 
- Safety and efficacy of drug use for longer than 3 weeks have not been established 
- Pregnancy and lactation : 
Used only if clearly needed due to lack of adequate and well-controlled studies in 
pregnant and lactating women . 
Drug- drug interactions : 
Not yet known . 
Side effects : 
It is well-tolerated . 
The following effects are rarely reported : 
Skin atrophy ( such as shiny, telangiectasia, loss of elasticity, loss of normal skin 
markings, thin and bruising ) , tingling , stinging V furunculosis, burning, pruritus 
rosacea, skin irritation, dryness, folliculitis, skin eruption, hypo pigmentation, 
perioral dermatitis, allergic contact dermatitis and secondary infections . 
Dosage and administration : 
- For dermatological use only as directed by physician . 
- For patients 2 years of age or older. 
- Treated area should not be bandaged or otherwise covered or wrapped so as to 
be occlusive unless directed by physician . 
_-Apply a thin film to the affected skin areas once daily with gentle massage . 
-Avoid over dose fora long period . 
Storage : 
Keep at temperature not exceeding 30 oc. 
Keep out of reach of children . 
Pack : 
Tube of 20 gram cream packed in a carton box with pamphlet. 
Produced by 
SEDICO Pharmaceutical Co. 
6 October City - Egypt 
P.o Box 43, Postal code No.: 12566 
U-