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INCEPTA PHARMACEUTICALS LTD.


Cyclopan

Indications.


Dosage


Side Effects



Cyclopan
Dicycloverine Hydrochloride tablet, syrup and injection

Presentation
Cyclopan tablet: Each tablet contains Dicycloverine Hydrochloride BP10 mg.
Cyclopan syrup: Each 5 ml syrup contains Dicycloverine Hydrochloride BP 10 mg.
Cyclopan injection: Each 2 ml injection contains Dicycloverine Hydrochloride BP 20 mg.

Description
Dicycloverine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Chemically, it is [Bicyclohexyl-]1-carboxylic acid, 2-(diethylammo) ethyl ester, hydrochloride. Dicycloverine relieves smooth muscle spasm of the gastrointestinal tract.

Dicycloverine HCl Injection is a sterile, pyrogen-free, aqueous solution for intramuscular
injection (Not For Intravenous Use).

It works at specific receptors, called cholinergic (or muscarinic) receptors, located on the involuntary muscle in the walls of the gut. By binding to these receptors dicycloverine prevents certain chemicals produced by the body from interacting with these receptors. This causes the gut muscle to relax, relieving the pain of colic produced by gut muscle contraction and spasm.

Indications and Uses
Functional bowel/irritable bowel syndrome
Urinary incontinence secondary to unstable detrusor muscle
Infantile colic
GIT spasm
Colicky abdominal pain
Diverticulitis
Abdominal colic

Contraindications
Obstructive uropathy
Obstructive disease of the gastrointestinal tract
Severe ulcerative colitis
Reflux esophagitis
Unstable cardiovascular status in acute hemorrhage
Glaucoma
Myasthenia gravis
Evidence of prior hypersensitivity to dicycloverine hydrochloride or other ingredients of this formulation
Infants less than 6 months of age

Dosage And Administration
For oral dosage forms
Adults-10 to 20 mg three times a day.
Children over 6 months of age- 5 to 10 mg three times a day.

For injectable dosage form:
Adults-Intramuscular injection. Not for intravenous use. The recommended intramuscular dose is 80 mg daily (in 4 equally divided doses).

Oral dicycloverine Hydrochloride should be started as soon as possible and the intramuscular form should not be used for periods longer than 1 or 2 days.
Children-Dose must be determined by the doctor.


Precautions
Use with caution in patients with autonomic neuropathy, hepatic or renal disease, ulcerative colitis, coronary heart disease, congestive heart failure, cardiac tachyarrhythmia, hiatal hernia, known or suspected prostatic hypertrophy.

Side Effects
Insomnia, mydriasis, cycloplegia, increased ocular tension, urinary hesitancy, palpitations, dyspnea.

Use in pregnancy & lactation
Pregnancy Category B. Dicycloverine was neither teratogenic nor embryocidal in animal trial. It, like other drugs should be used during pregnancy only if clearly needed. There are no data on the secretion of this drug into breast milk. Dicycloverine should be used cautiously in case of lactating mother.

Overdosage
Toxic reaction seldom occurs with dicycloverine. The signs and symptoms of overdosage are headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation.

Commercial Pack
Cyclopan tablet: Each box contains 10 blister strips of 10 tablets.
Cyclopan syrup: Each bottle contains Dicycloverine Hydrochloride 50 ml syrup.
Cyclopan injection: Each box contains 5 Ampoules of 2 ml solution of Dicycloverine Hydrochloride.
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