Dicyclomine Hydrochloride (Dicyclomine)

Trade Name : Dicyclomine

Hikma Pharmaceuticals USA Inc.

TABLET

Strength 20 mg/1

DICYCLOMINE HYDROCHLORIDE Anticholinergic [EPC],Cholinergic Antagonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Dicyclomine Hydrochloride (Dicyclomine) which is also known as Dicyclomine and Manufactured by Hikma Pharmaceuticals USA Inc.. It is available in strength of 20 mg/1 per ml. Read more

Dicyclomine Hydrochloride (Dicyclomine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions, Peripheral and Central Nervous System u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 07/2012
  • Dicyclomine hydrochloride tablets, USP are indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
  • Dicyclomine hydrochloride tablets, USP are an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome n
  • Dosage must be adjusted to individual patient needs.
  • The recommended initial dose is 20 mg four times a day.
  • After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.
  • If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.
  • Dosage for dicyclomine hydrochloride tablets must be adjusted to individual patient needsu00a0.
  • If a dose is missed, patients should continue the normal dosing scheduleu00a0.
  • Oral in adultsu00a0:
  • u2022 Starting dose: 20 mg four times a day. After a week treatment with the starting dose, the dose may be escalated to 40 mg four times a day, unless side effects limit dosage escalation
  • u2022 Discontinue dicyclomine hydrochloride if efficacy not achieved or side effects require doses less than 80 mg per day after two weeks of treatment
  • Dicyclomine hydrochloride 20 mg tablets: Blue, Round, Unscored Tablet; Debossed u201cWW 27u201d
  • Dicyclomine hydrochloride tablets 20 mg n
  • Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age nursing mothers and in patients with:
  • u2022 u00a0u00a0u00a0 unstable cardiovascular status in acute hemorrhage
  • u2022 u00a0u00a0u00a0 myasthenia gravis n
  • u2022 u00a0u00a0u00a0 glaucoma n
  • u2022 u00a0u00a0u00a0 obstructive uropathy n
  • u2022 u00a0u00a0u00a0 obstructive disease of the gastrointestinal tract n
  • u2022 u00a0u00a0u00a0 severe ulcerative colitis n
  • u2022 u00a0u00a0u00a0 reflux esophagitis
  • No data
  • Cardiovascular conditions:n- (5.2)
  • Peripheral and central nervous system:n- (5.3)
  • Psychosis and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness):n- (5.3)
  • Myasthenia Gravis:n- (5.4)
  • Incomplete intestinal obstruction:n- (5.5)
  • Salmonella dysenteric patients:n- (5.6)
  • Ulcerative colitis:n- (5.7)
  • Prostatic hypertrophy:n- (5.8)
  • Hepatic and renal disease:n- (5.9)
  • Geriatric:n- (5.10)
  • The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors n . They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system. These effects are dose-related and are usually reversible when treatment is discontinued.
  • The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms n
  • The most serious adverse reactions include cardiovascular and central nervous system symptoms. The most common adverse reactions (> 5% of patients) are dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousnessu00a0n
  • No data
  • Antiglaucoma agentsn- (7)
  • Anticholinergic agentsn- (7)
  • Antacidsn- (7)
  • No data
  • Pregnancy: use only if clearly needed n
  • Pediatric Use: Safety and effectiveness not established n
  • Hepatic and renal impairment: caution must be taken with patients with significantly impaired hepatic and renal function n u00a0
  • In case of an overdose, patients should contact a physician, poison control center (1-800-222-1222), or emergency room.
  • The 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.u00a0 A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).
  • One reported event included a 37-year-old who reported numbness on the left side, cold fingertips, blurred vision, abdominal and flank pain, decreased appetite, dry mouth, and nervousness following ingestion of 320 mg daily (four 20 mg tablets four times daily).u00a0 These events resolved after discontinuing the dicyclomine.
  • The acute oral LD of the drug is 625 mg/kg in mice. The amount of drug in a single dose that is ordinarily associated with symptoms of overdosage or that is likely to be life- threatening, has not been defined. The maximum human oral dose recorded was 600 mg by mouth in a 10-month-old child and approximately 1500 mg in an adult, each of whom survived.u00a0 In three of the infants who died following administration of dicyclomine hydrochloride , the blood concentrations of drug were 200, 220, and 505 ng/mL.
  • It is not known if dicyclomine hydrochloride is dialyzable.
  • Treatment should consist of gastric lavage, emetics, and activated charcoal. u00a0Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement.u00a0 If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.
  • Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available as:
  • Dicyclomine hydrochloride tablets, USP for oral use containing 20 mg dicyclomine hydrochloride, USP. Dicyclomine hydrochloride 20 mg tablets contain the following inactive ingredients: Anhydrous Lactose, FD&C Blue No. 1 Aluminum Lake, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose.
  • Dicyclomine hydrochloride is [bicyclohexyl]-1-u00adcarboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of CHNOu2022HCl and the following structural formula:
  • Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste.u00a0 It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.
  • No data
  • Long-term animal studies have not been conducted to evaluate the carcinogenic potential of dicyclomine. In studies in rats at doses of up to 100 mg/kg/day, dicyclomine produced no deleterious effects on breeding, conception, or parturition.
  • In controlled clinical trials involving over 100 patients who received drug, 82% of patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times daily) demonstrated a favorable clinical response compared with 55% treated with placebo (p<0.05).
  • Dicyclomine hydrochloride tablets, USP 20 mg are supplied as Blue, Round, Unscored Tablet; Debossed u201cWW 27u201d and are available in:
  • Bottles of 100 tabletsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0143-1227-01
  • Bottles of 1000 tabletsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0143-1227-10
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature]. Protect from light and moisture.
  • To prevent fading, avoid exposure to direct sunlight.
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • No data
  • NDC 0143-1227-01Dicyclomine Hydrochloride Tablets, USP20 mg100 TabletsRx Only

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