Ritemed Dicycloverine HCl

Dicycloverine hydrochloride.

Tablet: Each tablet contains: Dicycloverine Hydrochloride 10 mg.
Syrup: Each 5 mL (1 teaspoonful) syrup contains: Dicycloverine hydrochloride 10 mg.

Pharmacology: Tablet: Dicycloverine hydrochloride is an antimuscarinic agent with effects similar to but much weaker than those of atropine. It also has a direct antispasmodic action on smooth muscles and reduces secretions, especially salivary and bronchial secretions. It also reduces perspiration, but has a little effect on biliary or pancreatic secretion. Dicycloverine hydrochloride is used in the gastrointestinal spasm, particularly that associated with the irritable bowel syndrome and is also given in association with antacids as adjunct in the treatment of peptic ulcer.
Pharmacodynamics: Syrup: Dicycloverine is an anticholinergic agent that relieves muscle spasm of the gastrointestinal (GI) tract. Animal studies indicate that this action is achieved via a dual mechanism: a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites; and a direct effect upon smooth muscle (musculotropic).
Pharmacokinetics: Syrup: In man, dicycloverine is rapidly absorbed after oral administration, reaching peak values (mean of 58 ng/mL after a 20 mg dose) within 60 to 90 minutes. Mean volume of distribution for a 20 mg oral dose is approximately 3.65 L/kg, suggesting extensive distribution in tissues.
Metabolism of dicycloverine has not been investigated, while the principal route of excretion is via the urine (79.5% of the dose). Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose. In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life.

Tablet: For the treatment of gastrointestinal spasms, irritable colon and spastic constipation.
Syrup: Treatment of functional conditions involving smooth muscle spasm of the GI tract (e.g., mucus colitis, spastic colon and irritable bowel syndrome).

Tablet: Adults: 1 to 2 tablets three to four times daily dose not exceeding 40 mg, or, as prescribed by a physician.
Syrup: NOT recommended for infants less than 6 months old.
Dosage must be adjusted to individual patient needs.
Orally, 3 times a day, as needed.
Children 2 to 12 years old: 5 mL (1 teaspoonful).
Infants 6 months to <2 years old: 2.5 to 5 mL (1/2 to 1 teaspoonful); NOT to exceed 20 mL (40 mg) a day; administer 15 minutes before feeding; may be diluted immediately prior to use with water if needed.
Or, as prescribed by a physician.

Syrup: Symptoms: Signs and symptoms of overdosage include: headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation including convulsion.
A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).
Treatment: Treatment should consist of gastric lavage, emetics, and activated charcoal. Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement. If indicated, an appropriate parenteral cholinergic agent may be used as an antidote. It is not known if dicycloverine is dialyzable.

Hypersensitivity to dicycloverine or other ingredients in the product. Infants less than 6 months old; Patients with the following conditions: Myasthenia gravis, Obstructive uropathy, Obstructive disease of the GI tract, Paralytic ileus and intestinal atony, Severe ulcerative colitis.
Syrup: Unstable cardiovascular status in acute hemorrhage, Glaucoma, Reflux esophagitis. Breastfeeding women.

Tablet: Should be used with caution in patients with glaucoma, prostatic hypertrophy, hiatal hernia associated with reflux esophagitis.
Syrup: Nervous System Effects: The peripheral effects of dicycloverine are a result of its inhibitory effect on muscarinic receptors of the autonomic nervous system. These include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the GI tract leading to constipation.
In the presence of high environmental temperature, heat prostration car occur with drug use (fever and heatstroke due to decreased sweating). It should also be used cautiously in patients with fever. If symptoms occur, discontinue the drug and institute supportive measures. Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy. Central nervous system signs and symptoms include confusion, disorientation, short-term amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect.
Psychosis has been reported in sensitive individuals (patients with mental illness) given anticholinergic drugs.
These usually resolve within 12 to 24 hours after discontinuation of the drug.
Myasthenia gravis: With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). It is CONTRAINDICATED in patients with myasthenia gravis (see Contraindications).
Gastrointestinal Effects: Intestinal obstruction: Diarrhea may be an early symptom of incomplete intestinal obstruction, especially inpatients with ileostomy of colostomy. In this instance, treatment with dicycloverine is inappropriate and possibly harmful (see Contraindications).
Rarely, development of Ogilvie's syndrome (colonic pseudo-obstruction) has been reported. Ogilvie's syndrome is a clinical disorder with signs, symptoms, and radiographic appearance of an acute large bowel obstruction but with no evidence of distal colonic obstruction.
Toxic dilatation of intestine and megacolon: Toxic dilatation of the intestine and intestinal perforation is possible when anticholinergic agents are administered in patients with Salmonella dysentery.
Ulcerative colitis: Use with caution in patients with ulcerative colitis. Large doses may suppress intestinal motility to the point of producing a paralytic ileus and the use of this drug may precipitate or aggravate the serious complication of toxic megacolon. Dicycloverine is CONTRAINDICATED in patients with severe ulcerative colitis (see Contraindications).
Statement On Usage For High Risk Groups: Renal and Hepatic Impairment: Effects of renal and hepatic impairment on the pharmacokinetics, safety and efficacy of dicycloverine have not been evaluated. Dicycloverine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Dicycloverine should be administered with caution in these patients.
Use in Children: Dicycloverine is CONTRAINDICATED in infants <6 months old (see Contraindications and Precautions).
Use in Infants: There are published cases reporting that the administration of dicycloverine hydrochloride syrup to infants (3 months old) has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, coma, and death. In some instances, these symptoms occurred within minutes of ingestion and lasted up to 20 to 30 minutes. The symptoms were reported in association with dicycloverine syrup but a proven cause and effect relationship has not been established; however, it is CONTRAINDICATED in children <6 months old (see Contraindications).

Tablet: Side effects of dicycloverine hydrochloride are dryness of the mouth, with difficulty in swallowing and talking, thirst, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, constipation and headache.
Toxic doses cause tachycardia, rapid respiration, hyperpyrexia and CNS stimulation marked by restlessness, confusion, excitement, paranoid and psychotic reactions, hallucinations and delirium and occasionally seizures and convulsion.
Treatment of Adverse Effects: If overdoses have been taken by mouth, the stomach should be emptied by aspiration and lavage or by induction of emesis. The giving of activated charcoal to reduce absorption prior to lavage has been suggested.
Syrup: Adverse effects with dicycloverine are usually related to its pharmacological actions of inhibiting muscarinic receptors, including dry mouth, dizziness, blurred vision, nausea, light-headedness, somnolence, asthenia, and nervousness. These effects are dose-related and are usually reversible when treatment is discontinued.
The most serious adverse reactions reported include cardiovascular and nervous system effects (see Precautions).
Other adverse effects include: Immune System: Drug hypersensitivity including facial edema, angioedema, anaphylactic shock.
Psychiatric: Agitation, altered mood, amnesia (or transient global amnesia), confused state, delirium, delusion, disorientation, hallucination (including visual hallucination), mania, pseudodementia.
Nervous System: Dyskinesia, headache, insomnia, numbness, speech disturbance, syncope, tingling.
Eye: Cycloplegia, diplopia, increased ocular tension, mydriasis.
Cardiovascular: Hypertension palpitations, tachyarrhythmias.
Respiratory, Thoracic and Mediastinal: Apnea, dyspnea, nasal congestion, sneezing, throat congestion.
Gastrointestinal: Abdominal distention/pain, anorexia, constipation, dyspepsia, vomiting.
Skin and Subcutaneous Tissue: Allergic dermatitis, decreased sweating, erythema, itching, rash, urticaria.
Genitourinary/Reproductive: Impotence, suppressed lactation, urinary hesitancy, urinary retention.
General Disorders and Administration Site Conditions: Fatigue, malaise.

Syrup: Antacids: May interfere absorption of anticholinergics, including dicycloverine; avoid using concomitantly.
Anticholinergics: Increased anticholinergic effects of these agents, including amantadine, Class I antiarrhythmic agents (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, etc.
Antiglaucoma Agents: Antagonize the effects of antiglaucoma agents; anticholinergics in increased intraocular pressure may be hazardous when given with corticosteroids (see Contraindications).
Effect of Absorption of Other Drugs: May affect absorption of drugs affects by GI motility (e.g., slowly dissolving digoxin, leading to increased serum digoxin).
Effect on Gastric Acid Secretion: Inhibiting effect of anticholinergics are antagonized by agents used to treatachlorhydria and those used to test gastric secretion.
GI Motility Agents: Antagonize the effects (e.g., metoclopramide).
Tell the doctor if the patient is taking other medicines, including vitamins, supplements, and herbal medicines.

Store at temperatures not exceeding 30°C. Protect from light.
Syrup: Always keep container tightly closed.

Antispasmodics

A03AA07 - dicycloverine ; Belongs to the class of synthetic anticholinergics, esters with tertiary amino group. Used in the treatment of functional bowel disorders.

Rx

Tab 10 mg x 100's. Syr (clear, orange, banana flavored syrup) 10 mg/5 mL x 60 mL.