Dicyclomine Hydrochloride (Dicyclomine Hydrochloride)

Trade Name : Dicyclomine Hydrochloride

NuCare Pharmaceuticals, Inc.

CAPSULE

Strength 10 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 Hydrochloride) which is also known as Dicyclomine Hydrochloride and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 10 mg/1 per ml. Read more

Dicyclomine Hydrochloride (Dicyclomine Hydrochloride) 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

Validated Cold Chain Shipment

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
  • u00a0Warnings and Precautions, Peripheral and Central Nervous System (n n n ) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 07/2012n nn
  • Warnings and Precautions, Peripheral and Central Nervous System (n n n ) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 07/2012n nn
  • Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
  • Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome (n n n )n nn
  • 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 must be adjusted to individual patient needs (n n n ). If a dose is missed, patients should continue the normal dosing schedule (n n n ). n nn
  • Oral in adults (n n n ): n n n
  • 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
  • Discontinue dicyclomine hydrochloride if efficacy not achieved or side effects require doses less than 80 mg per day after two weeks of treatment
  • No data
  • Dicyclomine hydrochloride capsules 10 mg (n n n ) n n n
  • Dicyclomine hydrochloride tablets 20 mg (n n n )u00a0 n n n
  • Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age n n n , nursing mothers n n n , and in patients with: n nn
  • No data
  • Cardiovascular conditions
  • Peripheral and central nervous system
  • Psychosis and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness)
  • Myasthenia Gravis
  • Incomplete intestinal obstruction
  • Salmonella dysenteric patients
  • Ulcerative colitis
  • Prostatic hypertrophy
  • Hepatic and renal disease
  • Geriatric
  • The pattern of adverse effects seen with dicylomine is mostly related to its pharmacological actions at muscarinic receptorsu00a0n n 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.n nn
  • The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms n n n 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 nervousness (n n n )n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Watson Laboratories, Inc. at 1-800-272-5525 or FDA at 1-800-FDA-1088 or n n n n
  • No data
  • Antiglaucoma agents
  • Anticholinergic agents
  • Antacids
  • No data
  • Pregnancy: use only if clearly needed (n n n n n
  • Pediatric Use: Safety and effectiveness not established (n n n )n n n
  • Hepatic and renal impairment: caution must be taken with patients with significantly impaired hepatic and renal function (n n n )n n n
  • 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. 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). These events resolved after discontinuing the dicyclomine.
  • The acute oral LDn n n of the drug is 625 mg/kg in mice.n nn
  • 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. In three of the infants who died following administration of dicyclomine hydrochloride n n n the blood concentrations of drug were 200, 220, and 505 ng/mL.n nn
  • It is not known if dicyclomine hydrochloride is dialyzable.
  • 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.
  • Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms:
  • Dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of Cn n n Hn n n NOn n n u2022HCl and the following structural formula:n nn
  • Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. 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 Capsules USP are supplied as follows:
  • Dicyclomine hydrochloride Capsules n- WATSONn- 794
  • Store at Controlled Room Temperature 15u00b0-30u00b0C (59u00b0-86u00b0F).
  • Dispense in a well-closed container as defined in USP/NF.
  • No data
  • No data

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