Dicyclomine / Dicycloverine

Dicyclomine / Dicycloverine

10mg Tablet

10mg/5ml Syrup

DRUG CATEGORY:

Anticholinergic Drug/ Antispasmodic Drug

BRAND NAME:

Bentyl

PHARMACOLOGICAL ACTION:

Dicycloverine in hydrochloride as its salt, is tertiary amine with antimuscarinic effects similar to but weaker than those atropine. It also has a direct antispasmodic action.

PHARMACOKINETICS:

Dicycloverine is readily absorbed from the gastrointestinal tract; it is also absorbed from mucous membranes, the eye, and to some extent through intact skin. It is rapidly cleared from the blood and is distributed throughout the body. It crosses the blood-brain barrier. It is incompletely metabolized in the liver and is excreted in the urine as unchanged drug and metabolites. A half-life of about 4 hours has been reported. It crosses the placenta and traces appear in breast milk.

INDICATIONS:

For the treatment of functional gastrointestinal conditions including smooth muscle spasms, e.g. irritable colon (mucous colitis, spastic colon, irritable bowel syndrome) and spastic constipation. Adjunctive therapy in organic gastrointestinal conditions to relieve associated smooth muscle spasms (e.g. diverticulitis, regional enteritis, gastric, and peptic ulcers).

DOSAGE AND ADMINISTRATION:

Adults: 10mg to 20mg 3 to 4 times a day.

Children: 6 mos to 2 years – 5mg to 10mg 3 to 4 times daily. Dose does not exceed 40mg. 2yrs to 12 years – 10mg 3 times a day.

Elderly: older adults should begin with the lowest possible dose and increase their dosage only as needed.

Child (under 6 months): not recommended

Or as prescribed by a physician.

Dose is usually given 15 minutes before meals. If you forget to take a dose of Dicycloverine (Dicyclomine, in USA), take it as soon as you remember. If it is almost time for your nest dose, skip the forgotten dose and continue with your regular schedule.

CONTRAINDICATIONS:

It is contraindicated in patients with prostatic enlargement in whom it may lead to urinary retention, and in those with paralytic ileus or pyloric stenosis. In patients with ulcerative colitis its use may lead to ileus or megacolon, and its effects on the lower esophageal sphincter may exacerbate reflux. Caution is generally advisable in any patient with diarrhea. Its should not be given to patients with myasthenia gravis except to reduce adverse muscarinic effects of an anticholinesterase.

Antimuscarinic should not be given to patients with angle-closure glaucoma or with a narrow angle between the it is and the cornea, since it may raise intra-ocular pressure and precipitate an acute attack. Acute angle-closure glaucoma has been reported in patients receiving nebulized atropine. Some recommend that atropine eye drops should not be used in infants aged less than 3 months due to the possible association between the induced cycloplegia and the development of amblyopia. Systemic reactions have followed the absorption of atropine from eyes drops; overdosage is less likely if the eye ointment is used. In the event of blurred vision following topical administration of atropine to the eye patients should not drive or operate machinery. Systemic administration of antimuscarinics may also cause blurred vision, dizziness, and other effects that may impair a patients ability to perform skilled tasks such as driving.

Because of the risk of provoking hyperthermia, antimuscarinic should not be given to patients, especially children, when the ambient temperature is high. It should also be used cautiously in patients with fever.

Antimuscarinics need to be used with caution in conditions characterized by tachycardia such as thyrotoxicosis, heart failure, and in cardiac surgery, where they may further accelerate the heart rate. Care is required in patients with acute myocardial infarction, as ischemia and infarction may be made worse, and in patients with hypertension.

Antimuscarinics may cause confusion, especially in the elderly, Reduced bronchial secretion caused by systemic administration of antimuscarinic may be associated with the formation of mucous plugs.

In the treatment of parkinsonism, increases in dosage and transfer to other forms of treatment should be gradual and antimuscarinic should not be withdrawn abruptly. Minor reactions may be controlled by reducing the dose until tolerance has developed.

Persons with Down's syndrome appear to have an increased susceptibility to some of the actions of antimuscarinic, whereas those with albinism may have reduced susceptibility.

ADVERSE DRUG REACTIONS:

The pattern of adverse effects seen with atropine and other antimuscarinics can mostly be related to their pharmacological actions at muscarinic and, at high doses, nicotinic receptors. These effects are dose-related and are usually reversible when therapy is discontinued. The peripheral side-effects of antimuscarinic are a consequence of their inhibitory effects include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cyclopegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitation and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation.

PRECAUTIONS AND WARNINGS:

It should be given with caution to children and geriatric patients, who may be more susceptible to its adverse effects. It is contraindicated in patients, who may be more susceptible to its adverse effects. It is contraindicated in patients with prostatic enlargement and in those with paralytic ileus or pyloric stenosis. In patients with ulcerative colitis, myasthenia gravis, and closed-angle glaucoma and in patients taking antimuscarinic agents in conditions characterized by tachycardia such as thyrotoxcosis, cardiac insufficiency, or failure and in cardiac surgery.

Pregnancy and Lactation:

A few cases of human malformation were linked to Dicycloverine, but studies have shown that the drug has not effect on the developing baby. As with all other drug products, Dicycloverine should be used during pregnancy only when absolutely necessary.

Dicycloverine or Dicyclomine should not be used by nursing mothers because like other drugs in is group, it may reduce the amount of milk produced. Also, a few infants less than 3 months o age who were given Dicycloverine drops developed breathing difficulty that went away on its own after 20 to 30 minutes.

Use in Elderly:

Older adults may be more susceptible to the side effects of the drug, especially memory loss, mental changes, and glaucoma, and may need less medicine to get a beneficial effect than a younger adult. Report any problems to your doctor at once.

Effects on ability to drive and operate machinery:

Oral administration of antimuscarinics such as Dicycloverine may cause blurred vision, dizziness, and other effects that may impair a patients ability to perform skilled tasks such as driving and operating machinery.

DRUG INTERACTIONS:

1. Never mix Dicycloverine with other anticholinergic drugs, including Atropine, Belladonna, Clidinium, Glycopyrrolate, Hyoscyamine, Isopropamide, Propantheline, Scopolamine, and others because of the possibility of intensifying drug adverse effects.
2. Dicycloverine can reduce stomach acidity and reduce the amount of Ketoconazole absorbed into the blood after it is taken by mouth.
3. Antacids containing calcium and/or magnesium citrates, sodium bicarbonate, and carbonic anhydrase inhibitor drugs may slow the rate at which Dicycloverine is released from the blood, increasing its therapeutic effect and possible side-effects.
4. Taking Dicycloverine may counteract the effect of Metoclopramide in reducing nausea and vomiting when taken together.
5. Dicycloverine together with narcotic pain reliever can increase the chances of severe constipation.
6. Taking this drug or any other drug that slows the movement of stomach and intestinal muscles together with a potassium chloride supplement (especially one that comes in wax-matrix tablet form) can lead to excessive irritation of the stomach.

OVERDOSAGE:

The principal signs of overdose are blurred vision; clumsiness; confusion; difficulty breathing; dizziness; drowsiness; dry mouth, nose, or throat; rapid heartbeat; fever; hallucinations; weakness; slurred speech; excitement, restlessness, or irritability; warmth; and dry or flushed skin. Overdose victims should be taken to a hospital emergency room at once for treatment. Always bring the medicine with you.

STORAGE CONDITIONS:

Store at temperatures not exceeding 30^oC. Protect from light.