 |
| CLARINASE* REPETABS |
I’ll’’ 150225099014 CLARINASE* REPETABS* TABLETS EM-JRPD4naB
Brand of loratadina and pseudoephedrine sulfate
Long-Acting, Non-sedating Antihislamineloecongestant Tablets
DESCRIPTION: Each CLARtNASE REPETABS* tablet contains 5mg Lorafadise in the tablet coating aed 120 mg pseuduephedrise sulfate equally distributed
between the tablets coating and the bamer-coated cone. The two active components in the coating are quickly liberated; release of the decongestant in the cow is delayed
for several boom. Inactive ingredients; maize starch, povidona, magnesium stearete, end purified water.
ACTIONS: Loratadine isa potent long-acting tricyclic antihistamine with selective peripheral Nt - receptor antagonistic activity. Pseudsephedrine sulfate, one of the naturally
occutring alkaloids of Ephedra andes orally administemd vanoconstrictor. pmduces a gradual but sustained decongestant effect facilitating shrinkage of congested mucosa in
upper respiratory areas.
The mucosa membrane of the respiratory tract is dacosgested through the action on the sympathetic nerves.
INDICATIONS AND USAGE: Clurinasa Rapatabs Tablets am indicated for the relief of symptoms associated with allergic rhinitis and the common cold including nasal —
congesf on, sneezing, thinurthea , pruritus and lucrimation. Ctsrinase Rapetabs Tablets are recommended when both the untihistaminic propartiau of loraladina and the —‘
decongestant effect of pseudsepheddee sulfate are desimd.
DOSAGE ANDADMINISTRATION: Molts and Children 12 yeum of age and over One Clef nasa RepetsbsTablettmice a day.
DRUG INTERACTIONS: When administered concomitantlywith alcohol, loratadise basso potenbating effectas measured bypaychsmolorperfnrmnnce studies.
Increase in plasma concentrations of loratadine kane been reported after concomitant use with ketoconuzule, erythromycin or ctreatidina in controlled clinical trials, but without
clinically aignibcant changes )iscludisg elecfrucardiographic).Other drugs known to inhibit hepaftc metabolism should be coadminiulerad with caution unbi definitive interaction
studies con be completed.
When syrapathomimaf no am gives to patients receiving monoamine soidase (MAO) inhibitsra, hypertensive reactions, including hypertensive crises may scour. The
antihypertensive effects of mathyldopa, macamylamrne, reserpine and varatmm alkaloids may be reduced by sympathomimetics. Bats-adrenergic blocking agents may also
interact with nympathomimetico. Increased ectopic pacemaker activity can occur when pueudoepheddna is used concomitanfy with digitalis. Antacids increase the rate of
pseudoepheddneabsorpton; kaolin decreases it
Drug/Laboratory Test Ieteractiees; Anfthiutaminen should be diuconb sued approcimalely4fi houra prior to skin testing procedures since these drugs may prevent or diminish
othermisv positive reactions to dermul reacbvity indicators.
The in vitro addition of psaudoaphedrina to sera containing the cardiac isoenzyme MB of serum creatine phnnphokinuse progressively inhibits the activity of the enzyme. The
inhibition becomes complete over sia houra.
ADVERSE REACTIONS: During controlled clinical studies with the recommended dosage, the incidence of adverse effects associated with Clarinane Repetabs Tablets was
comparable to that of placebo, with the euception of insomnia and dry mouth, both of which were commonly reported. Other reported adveme reactions associated with both
ClarinunoRepefabsTablatn.evd placebo-included headache-and somnolence. - - - - -
Rare adverse raacbons in decreasing order of frequency included nervousness, dizzinens, fabgue, nausea, abdominal distress, anoreuia, thirat, tachycardia, pharyngrbn,
rhinite, acne, praritus, rash, urticaria, arthralgia, confusion, dysphonia, hypertcinesia, hypoesthesia, decreased libido, poresthesia, tremor, vertigo, flushing, postural
hypolansion, increased sweating, aye diserdem, earache, hnnitun, taste abnormality, agitahon. apathy, dapreraion, euphoria. paranairia, increased appetite, change in bowel
habits, dyspepsia, eractabon. hemorrhoids, tongue discoloration, tongue disorder, vomiting. trans’renlabnormal hepabc function dehydration, increases weight hypertension,
palpitation, migraine, bronchospanm, coughing, dyspnea, apinlavis, nasal congestion, sneezing, nasal imtabnn, dysuria, mrctunhon disorder, noctuna, polyuna. urinary
retention, asthenia, back pain, leg cramps, malaise and rigora.
Dating the marketing of loratadina, alopocta. anaphylania, and abnormal hepabc function have been reported rarely.
CONTRAINDICATIONS: Clarinasn Repatabs Tablets are contraindicated in those who have shown nvnnitin’dy or id’msyncranyto their components, to adrenergic agents or
other drugs of similar chemical structure. Clarinane Rapotabs Tablets also are contraindicaled in patients receiving MAO inhibitor therapy, or within fourteen days of
discontinuing such treatment, and in patients with narrow angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease and hyperthyroidism.
PRECAUTIONS: Syrepathomimetics should be used with caution in patients with gtsucoma, ulvnosing peptic ulcer, pylorodaodenal obstruction, prontatic hyportrophy or
bladder neck obstruction, cardiovascular disease, increased intraocular pressure or diabetes mellitss. Syrepathoreimetics should be used with caution in pafiants receiving
digitalis. Sympathomimetics may cause central nervous system )CNS) sbreulabnn, encitability, convulsions, and/or cardiovascular collapse with accompanying hypotension.
Patient 60 year of age are more likely to have adveran reactions to sympathowimatics amines (such as paeudoepheddne). Consequently, caution should be nuercised when
administering a repeat action formulation to eldedy patients. Patients with severe liner impairment should be administered a lower initial dune because they may have reduced
clearance of loratadine; an initial dose of ova tableldaily is recommended.
Drug Abuse and Dependence: There are no data available to indicate that abase or dependency occurs with loratadine pseadoephedrine sulfate, like other CNS
stimulants, han bean abused.At high doses sub)ects commonly euperience an elevation of mood, decreased appetite and a senue of increased physical energy, mental capacity
and alertness. Anniety, irritability and loquacity also have been ecyarienced. With continued use, tolerance develops, the user increases the dose and ultimately tonicity occum.
Depression reayfollow rapid withdrawal.
PEDIATRIC USAGE; Safety and efficacy of Clannane Repetabu Tablets in children younger than 12 yeam of age have not yet been established.
USAGE DURING PREGNANCYAND IN NURSING MOTHERS: Safe use of Clarinasa Rapatabs Tablets daring pregnancy has not been established. Therefore, the
predaclshnald be used only if the potential benefttjunbfles the potential rishtolhe fetus.
Since loratadine and paeadoephedrine sulfate are eucreled in breast milk, a decision should be made whether to discontinue naraing or to discontinue the use of this
product.
OVERDOSAGE INFORMATION: In the event of overdonage. general symptomatic and supportive treatment should be started immediately and maintained for an long as
necessary.
Manifestations; They may vary bore CNS depression )sedation, apnea, diminished mental alertness, cyanosis, coma, cardiovascular collapse) In stimulation (insomnia,
hallucination, tremors or convulsions) to death. Other signs and spraptores may be eupberia, aucriement tachycardia, palpitabonn, thirat, parapiration, nausea, dizziness,
tinnitss, alania, blurred vision and hypertension or hypolension. Stimelaiton is parbcolariy likely is children, as are atropine-like signs and symptoms (dry mouth, fned dilated
pupils; fiunhing; hyporthermia. and gastrointestinal spreptown). In large doses sympathomireetica may give rise to giddiness, headache, nausea, vomiting, sweating, thirat,
tachycardia, precordial pain, palpitations, difficulty in mictadbco, muscular weakness and tsnseness, anniety, rectlessness and insomnia. Many patients can present a tooic
psychosis with delusions and halluctnabons. Sowe may develop cardiac amfrythreias, ctrculatory collapse, convulsions, coma and respiratory failure. The Oral LDSO values for
this combination preduct were greaterthan 525 and 1639 mg/kg in mice and rats respectively.
Treatmenc Cnnsider standard measures to rerenve any unabsorbed drug in the stomach, such as adsorption by activated charcoal adreinistered as a slurry with water The
administration of gastric luvage should by considerad. Physiologic sulintisdluliov is the luvage solution of choice, particularly in children. lv adults, tap wafer can be used;
however as machan possible of the amount administered shouta be removed before the nact instillation. Saline catharbca draw waler into thu bowel by osmosis and, therefore,
— maybe valuable for their action in rapid dilution of bowel contenf. After emergency treatment, the patient should continue lobe medically reontiured. Treatment of the signs and
— symptoresofoverdosage is nymptoreaftc and supportive. Stimulants barbf crates, diazepam or paraldehyde reap be adreinictered to control seizures. N yperpyreaia especially in
children may require treatmentwith tepid water, sponge baths or hypothermic blanket. Apnaa is treated with Vantilatory Support.
HOW SUPPLIED: Clad nasa RapetabuTablatsaresapplied in boo l4tabtats )2stfpsu Ttsblets).
STORAGE: Wore between 2’and 30’C. Protect bore encessha moisture.
‘Trademarks
Manufactured by;
Medlcat Uelee Pharmaceuticals,
Aba-Sultan, lareallia, Egypt. MUP Under authority of;
Schering-Pteagh CerparatleetU.S.A.
@1997, 1992, 1994 1995, Schedng-Plnvgh Corporation/U.S.A.
Schefeg-Plough Corporation/U.S.A.
Brand of loratadina and pseudoephedrine sulfate
Long-Acting, Non-sedating Antihislamineloecongestant Tablets
DESCRIPTION: Each CLARtNASE REPETABS* tablet contains 5mg Lorafadise in the tablet coating aed 120 mg pseuduephedrise sulfate equally distributed
between the tablets coating and the bamer-coated cone. The two active components in the coating are quickly liberated; release of the decongestant in the cow is delayed
for several boom. Inactive ingredients; maize starch, povidona, magnesium stearete, end purified water.
ACTIONS: Loratadine isa potent long-acting tricyclic antihistamine with selective peripheral Nt - receptor antagonistic activity. Pseudsephedrine sulfate, one of the naturally
occutring alkaloids of Ephedra andes orally administemd vanoconstrictor. pmduces a gradual but sustained decongestant effect facilitating shrinkage of congested mucosa in
upper respiratory areas.
The mucosa membrane of the respiratory tract is dacosgested through the action on the sympathetic nerves.
INDICATIONS AND USAGE: Clurinasa Rapatabs Tablets am indicated for the relief of symptoms associated with allergic rhinitis and the common cold including nasal —
congesf on, sneezing, thinurthea , pruritus and lucrimation. Ctsrinase Rapetabs Tablets are recommended when both the untihistaminic propartiau of loraladina and the —‘
decongestant effect of pseudsepheddee sulfate are desimd.
DOSAGE ANDADMINISTRATION: Molts and Children 12 yeum of age and over One Clef nasa RepetsbsTablettmice a day.
DRUG INTERACTIONS: When administered concomitantlywith alcohol, loratadise basso potenbating effectas measured bypaychsmolorperfnrmnnce studies.
Increase in plasma concentrations of loratadine kane been reported after concomitant use with ketoconuzule, erythromycin or ctreatidina in controlled clinical trials, but without
clinically aignibcant changes )iscludisg elecfrucardiographic).Other drugs known to inhibit hepaftc metabolism should be coadminiulerad with caution unbi definitive interaction
studies con be completed.
When syrapathomimaf no am gives to patients receiving monoamine soidase (MAO) inhibitsra, hypertensive reactions, including hypertensive crises may scour. The
antihypertensive effects of mathyldopa, macamylamrne, reserpine and varatmm alkaloids may be reduced by sympathomimetics. Bats-adrenergic blocking agents may also
interact with nympathomimetico. Increased ectopic pacemaker activity can occur when pueudoepheddna is used concomitanfy with digitalis. Antacids increase the rate of
pseudoepheddneabsorpton; kaolin decreases it
Drug/Laboratory Test Ieteractiees; Anfthiutaminen should be diuconb sued approcimalely4fi houra prior to skin testing procedures since these drugs may prevent or diminish
othermisv positive reactions to dermul reacbvity indicators.
The in vitro addition of psaudoaphedrina to sera containing the cardiac isoenzyme MB of serum creatine phnnphokinuse progressively inhibits the activity of the enzyme. The
inhibition becomes complete over sia houra.
ADVERSE REACTIONS: During controlled clinical studies with the recommended dosage, the incidence of adverse effects associated with Clarinane Repetabs Tablets was
comparable to that of placebo, with the euception of insomnia and dry mouth, both of which were commonly reported. Other reported adveme reactions associated with both
ClarinunoRepefabsTablatn.evd placebo-included headache-and somnolence. - - - - -
Rare adverse raacbons in decreasing order of frequency included nervousness, dizzinens, fabgue, nausea, abdominal distress, anoreuia, thirat, tachycardia, pharyngrbn,
rhinite, acne, praritus, rash, urticaria, arthralgia, confusion, dysphonia, hypertcinesia, hypoesthesia, decreased libido, poresthesia, tremor, vertigo, flushing, postural
hypolansion, increased sweating, aye diserdem, earache, hnnitun, taste abnormality, agitahon. apathy, dapreraion, euphoria. paranairia, increased appetite, change in bowel
habits, dyspepsia, eractabon. hemorrhoids, tongue discoloration, tongue disorder, vomiting. trans’renlabnormal hepabc function dehydration, increases weight hypertension,
palpitation, migraine, bronchospanm, coughing, dyspnea, apinlavis, nasal congestion, sneezing, nasal imtabnn, dysuria, mrctunhon disorder, noctuna, polyuna. urinary
retention, asthenia, back pain, leg cramps, malaise and rigora.
Dating the marketing of loratadina, alopocta. anaphylania, and abnormal hepabc function have been reported rarely.
CONTRAINDICATIONS: Clarinasn Repatabs Tablets are contraindicated in those who have shown nvnnitin’dy or id’msyncranyto their components, to adrenergic agents or
other drugs of similar chemical structure. Clarinane Rapotabs Tablets also are contraindicaled in patients receiving MAO inhibitor therapy, or within fourteen days of
discontinuing such treatment, and in patients with narrow angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease and hyperthyroidism.
PRECAUTIONS: Syrepathomimetics should be used with caution in patients with gtsucoma, ulvnosing peptic ulcer, pylorodaodenal obstruction, prontatic hyportrophy or
bladder neck obstruction, cardiovascular disease, increased intraocular pressure or diabetes mellitss. Syrepathoreimetics should be used with caution in pafiants receiving
digitalis. Sympathomimetics may cause central nervous system )CNS) sbreulabnn, encitability, convulsions, and/or cardiovascular collapse with accompanying hypotension.
Patient 60 year of age are more likely to have adveran reactions to sympathowimatics amines (such as paeudoepheddne). Consequently, caution should be nuercised when
administering a repeat action formulation to eldedy patients. Patients with severe liner impairment should be administered a lower initial dune because they may have reduced
clearance of loratadine; an initial dose of ova tableldaily is recommended.
Drug Abuse and Dependence: There are no data available to indicate that abase or dependency occurs with loratadine pseadoephedrine sulfate, like other CNS
stimulants, han bean abused.At high doses sub)ects commonly euperience an elevation of mood, decreased appetite and a senue of increased physical energy, mental capacity
and alertness. Anniety, irritability and loquacity also have been ecyarienced. With continued use, tolerance develops, the user increases the dose and ultimately tonicity occum.
Depression reayfollow rapid withdrawal.
PEDIATRIC USAGE; Safety and efficacy of Clannane Repetabu Tablets in children younger than 12 yeam of age have not yet been established.
USAGE DURING PREGNANCYAND IN NURSING MOTHERS: Safe use of Clarinasa Rapatabs Tablets daring pregnancy has not been established. Therefore, the
predaclshnald be used only if the potential benefttjunbfles the potential rishtolhe fetus.
Since loratadine and paeadoephedrine sulfate are eucreled in breast milk, a decision should be made whether to discontinue naraing or to discontinue the use of this
product.
OVERDOSAGE INFORMATION: In the event of overdonage. general symptomatic and supportive treatment should be started immediately and maintained for an long as
necessary.
Manifestations; They may vary bore CNS depression )sedation, apnea, diminished mental alertness, cyanosis, coma, cardiovascular collapse) In stimulation (insomnia,
hallucination, tremors or convulsions) to death. Other signs and spraptores may be eupberia, aucriement tachycardia, palpitabonn, thirat, parapiration, nausea, dizziness,
tinnitss, alania, blurred vision and hypertension or hypolension. Stimelaiton is parbcolariy likely is children, as are atropine-like signs and symptoms (dry mouth, fned dilated
pupils; fiunhing; hyporthermia. and gastrointestinal spreptown). In large doses sympathomireetica may give rise to giddiness, headache, nausea, vomiting, sweating, thirat,
tachycardia, precordial pain, palpitations, difficulty in mictadbco, muscular weakness and tsnseness, anniety, rectlessness and insomnia. Many patients can present a tooic
psychosis with delusions and halluctnabons. Sowe may develop cardiac amfrythreias, ctrculatory collapse, convulsions, coma and respiratory failure. The Oral LDSO values for
this combination preduct were greaterthan 525 and 1639 mg/kg in mice and rats respectively.
Treatmenc Cnnsider standard measures to rerenve any unabsorbed drug in the stomach, such as adsorption by activated charcoal adreinistered as a slurry with water The
administration of gastric luvage should by considerad. Physiologic sulintisdluliov is the luvage solution of choice, particularly in children. lv adults, tap wafer can be used;
however as machan possible of the amount administered shouta be removed before the nact instillation. Saline catharbca draw waler into thu bowel by osmosis and, therefore,
— maybe valuable for their action in rapid dilution of bowel contenf. After emergency treatment, the patient should continue lobe medically reontiured. Treatment of the signs and
— symptoresofoverdosage is nymptoreaftc and supportive. Stimulants barbf crates, diazepam or paraldehyde reap be adreinictered to control seizures. N yperpyreaia especially in
children may require treatmentwith tepid water, sponge baths or hypothermic blanket. Apnaa is treated with Vantilatory Support.
HOW SUPPLIED: Clad nasa RapetabuTablatsaresapplied in boo l4tabtats )2stfpsu Ttsblets).
STORAGE: Wore between 2’and 30’C. Protect bore encessha moisture.
‘Trademarks
Manufactured by;
Medlcat Uelee Pharmaceuticals,
Aba-Sultan, lareallia, Egypt. MUP Under authority of;
Schering-Pteagh CerparatleetU.S.A.
@1997, 1992, 1994 1995, Schedng-Plnvgh Corporation/U.S.A.
Schefeg-Plough Corporation/U.S.A.
No comments:
Post a Comment