Super Apeti Cyproheptadine Tablets

Super Apeti®

(Cyproheptadine Tablets BP)

 

Composition

SUPER APETI tablets

Each uncoated tablet contains: Cyproheptadine Hydrochloride equivalent to Anhydrous Cyproheptadine Hydrochloride BP 4mg.

Excipients: Calcium Hydrogen Phosphate BP, Lactose BP, Maize Starch BP, Purified Talc BP, Magnesium Stearate BP, Gelatin BP and Sodium Benzoate BP.

 

Pharmacologlcal category

SUPER APETI is an antihistaminic and antiserotonergic agent.

 

Pharmacotogicat action

SUPER APETI is a serotonin and histaminic antagonist with anticholinergic and sedative effects. It also blocks Ca+2 channels in pancreatic islet cells and smooth muscles.

 

Pharmacokinetics

Oral Absorption good

Mean plasma concentration 30 µg/L.

Plasma half-life 8 hour

Elimination: Urine (80%), Faeces (2 to 20%)

 

Therapeutic indications

SUPER APETI is indicated for the treatment of loss of appetite and allergy and pruritus.

 

Contraindications

SUPER APETI is not suitable to the patients with prostate hypertrophy, urinary retention, glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction. It is also not suitable to debilitated patients, patients with known hypersensitivity to cyproheptadine. SUPER APETI should not be used for the treatment of an acute asthmatic attack.

 

Dosage and directions for use

As an Appetite Stimulant

Adults and children (7 to 14 years): The usual dose is 1 tablet thrice daily. Maximum daily dose is 16mg. Children (2 to 6 years): ½ tablet thrice daily. Maximum daily dose is 8mg.

Pruritus and allergy

Children (2 to 6 years): ½ tablet thrice daily (0.25mg/kg/day). Maximum daily dose is 8mg.

Children (7 to 14 years): 4mg thrice daily. Maximum daily dose is 16mg. Adults: 4mg thrice daily, adjust as required. Maximum daily dose is 32mg.

 

Adverse reaction

Rarely observed side effects are dizziness, fatigue, headache etc. Prolong use of SUPER APETI may result into confusion, sedation, dry mouth, blurred vision, urinary retention, gastrointestinal disturbances etc.

 

Warnings and precautions for use in special populations

General

Prolonged therapy with SUPER APETI may cause blood dyscrasias. Due to the atropine-like action of cyproheptadine, it should be used with caution in patients with a history of bronchial asthma, hyperthyroidism, increased intraocular pressure, cardiovascular disease and hypertension.

Pediatric use

Contra-indicated in children less than 2 years.

Pregnancy and lactation

Safety in pregnancy and lactation has not been established.

Geriatric use

Dizziness, sedation and hypotension is more likely to occur in elderly patients.

 

Usage in Pregnancy and Lactation

SUPER APETI should be used during pregnancy with caution. Because of the higher risk of antihistamines for infants generally, and for newborns and prematures in particular, antihistamine therapy should be avoided in nursing mothers.

 

Effects on ability to drive and operate machinery

Tasks requiring mental alertness maybe impaired and patients whose work or occupations involves driving vehicles or handling machinery should be cautioned.

 

Drug interactions

Alcohol and CNS depressants

Increase CNS depression.

MAOIs

Increases anticholinergic effects.

Atropin and TCAs

Increase antimuscarinic effects.

Aminoglycosides

Ototoxicity masked.

 

Symptoms of over dosage and its treatment

Signs and symptoms of cyproheptadine overdosage may vary from hallucinations and central nervous system depression or stimulation to convulsions and death, especially in infants and children. Atropine-like effects (dry mouth, fixed dilated pupils, flushing, etc), as well as gastro-intestinal symptoms may occur. If overdosage occurs, the patient should be monitored, and standard supportive treatment applied as required. If vomiting has not occurred spontaneously, vomiting should be induced if the patient is conscious or the patient should be subjected to gastric lavage. Stimulants should not be used. Hypotension may be treated with vasopressors.

 

Storage condition

Do not store above 30oC. Protect from sunlight. Keep out of reach of children.

 

Presentation

SUPER APETI tablets: Pack of 20 tablets.

 

Publication Date

22/6/2016

 

Manufactured by

SHALINA LABORATORIES PVL LTD.

96, Maker Chambers VI, Nariman Point,

Mumbai – India.

 

At / A / Em

Plot No. -2, M.I.D.C. Jejuri,

Tal. Purandar, Dist. Pune,

Maharashtra – India.

www.shalina.com