apdine syrup - Lomus Pharmaceuticals Pvt. Ltd.

apdine syrup - Lomus Pharmaceuticals Pvt. Ltd. apdine syrup - Lomus Pharmaceuticals Pvt. Ltd.

05.04.2014 Views

APDINE Tablet/Syrup Dosage Forms/Composition Each uncoated tablet contains Cyproheptadine HCL mg. Each 5ml of suspension contains cyproheptadine HCL equivalent to anhydrous cyproheptadine HCL 2mg. Pharmacological Index Antihistamine INDICATION Perennial and seasonal allergic rhinitis and other allergic symptoms including urticaria. Appetite enhancer Pregnancy Risk Factor B Contraindications Hypersensitivity to cyproheptadine or any component; narrow-angle glaucoma, bladder neck obstruction, acute asthmatic attack, stenosing peptic ulcer, GI tract obstruction, those on MAO inhibitors; avoid use in premature and term newborns due to potential association with SIDS Warnings/Precautions Do not use in neonates, safety and efficacy have not been established in children 10%: Central nervous system: Slight to moderate drowsiness Respiratory: Thickening of bronchial secretions 1% to 10%: Central nervous system: Headache, fatigue, nervousness, dizziness Gastrointestinal: Appetite stimulation, nausea, diarrhea, abdominal pain, xerostomia Neuromuscular & skeletal: Arthralgia Respiratory: Pharyngitis

APDINE Tablet/Syrup<br />

Dosage Forms/Composition<br />

Each uncoated tablet contains Cyproheptadine HCL mg.<br />

Each 5ml of suspension contains cyproheptadine HCL equivalent to anhydrous<br />

cyproheptadine HCL 2mg.<br />

Pharmacological Index<br />

Antihistamine<br />

INDICATION<br />

Perennial and seasonal allergic rhinitis and other allergic symptoms including urticaria.<br />

Appetite enhancer<br />

Pregnancy Risk Factor<br />

B<br />

Contraindications<br />

Hypersensitivity to cyproheptadine or any component; narrow-angle glaucoma,<br />

bladder neck obstruction, acute asthmatic attack, stenosing peptic ulcer, GI tract<br />

obstruction, those on MAO inhibitors; avoid use in premature and term newborns due<br />

to potential association with SIDS<br />

Warnings/Precautions<br />

Do not use in neonates, safety and efficacy have not been established in children 10%:<br />

Central nervous system: Slight to moderate drowsiness<br />

Respiratory: Thickening of bronchial secretions<br />

1% to 10%:<br />

Central nervous system: Headache, fatigue, nervousness, dizziness<br />

Gastrointestinal: Appetite stimulation, nausea, diarrhea, abdominal pain, xerostomia<br />

Neuromuscular & skeletal: Arthralgia<br />

Respiratory: Pharyngitis<br />


useful by reducing acetylcholinesterase. Anticholinesterase inhibitors include<br />

physostigmine, neostigmine, pyridostigmine, and edrophonium. For anticholinergic<br />

overdose with severe life-threatening symptoms, physostigmine 1-2 mg (0.5 mg or 0.02<br />

mg/kg for children) I.V., slowly may be given to reverse these effects.<br />

Drug Interactions<br />

Increased toxicity: MAO inhibitors hallucinations<br />

Mechanism of Action<br />

A potent antihistamine and serotonin antagonist, competes with histamine for H1-<br />

receptor sites on effector cells in the gastrointestinal tract, blood vessels, and<br />

respiratory tract<br />

Pharmacodynamics/Kinetics<br />

Metabolism: Almost completely<br />

Elimination: >50% excreted in urine (primarily as metabolites); ~25% excreted in<br />

feces<br />

Usual Dosage<br />

Oral:<br />

2-6 years: 2 mg every 8-12 hours (not to exceed 12 mg/day)<br />

7-14 years: 4 mg every 8-12 hours (not to exceed 16 mg/day)<br />

Adults: 4-20 mg/day divided every 8 hours (not to exceed 0.5 mg/kg/day)<br />

Dosing adjustment in hepatic impairment: Dosage should be reduced in patients with<br />

significant hepatic dysfunction<br />

Patient Information<br />

Take as directed; do not exceed recommended dose. Avoid use of other depressants,<br />

alcohol, or sleep-inducing medications unless approved by prescriber. You may<br />

experience drowsiness or dizziness (use caution when driving or engaging in tasks<br />

requiring alertness until response to drug is known); or dry mouth, nausea, or<br />

abdominal pain (frequent small meals, frequent mouth care, chewing gum, or sucking<br />

hard candy may help). Report persistent sedation, confusion, or agitation; changes in<br />

urinary pattern; blurred vision; chest pain or palpitations; sore throat difficulty<br />

breathing or expectorating (thick secretions); or lack of improvement or worsening or<br />

condition. Breast-feeding precautions: Do not breast-feed.<br />

LOMUS Drug Information Center<br />

<strong>Lomus</strong> <strong>Pharmaceuticals</strong> <strong>Pvt</strong>. <strong>Ltd</strong>.<br />

P.O. Box No 4506, <strong>Lomus</strong> House (Corporate office),<br />

Kailash Chour, Lazimpat, Kathmandu, Nepal<br />

Ph: 4436396 (Hunting Line). Fx: 977-1-4436395<br />

E-mail: druginfo@lomus.com.np

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