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Active Ingredient: DicyclomineBentyl is used for the treatment of functional bowel/irritable bowel syndrome.

Other names for this medication: Algermin, Bentylol, Berclomine, Byclomine, Colchimax, Colicon, Colimix, Cosaichill, Cyclominol, Cyclopam, Cyclopan, Cymine, Dibent, Diciclomina,  Dicicloverina, Dicomin, Dicycloverin, Dicycloverine, Dicycloverinum, Dicymine, Difemic, Formulex, Kolantyl, Loverin, Magesan p,  Mainnox, Merbentyl, Notensyl, Or-tyl, Relestal, Resporix, Trigan.

DESCRIPTION

Berclomine (Dicyclomine Hydrochloride) is an antispasmodic and anticholinergic (antimuscarinic) agent. Berclomine (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.

Chemically, it is [Bicyclohexyl]-1-carboxylic acid, 2-(diethyl-amino) ethyl ester, hydrochloride with the following structural formula:

C19H35NO2-HCI   345.95

Each capsule, for oral administration, contains 10 mg of Berclomine (Dicyclomine Hydrochloride).

Each tablet, for oral administration, contains 20 mg of Berclomine (Dicyclomine Hydrochloride).

This product contains the following inactive ingredients: colloidal silicon dioxide (tablets only), corn starch (tablets only), D&C red #28 (capsules only), FD&C blue #1 (capsules only), FD&C blue #1 lake (tablets only), FD&C red #40 (capsules only), gelatin (capsules only), hypromellose (tablets only), lactose monohydrate (tablets only), magnesium stearate (capsules only), pregelatinized starch, silicon dioxide (capsules only), sodium lauryl sulfate (capsules only), sodium starch glycolate (tablets only), and stearic acid (tablets only).

Berclomine (Dicyclomine Hydrochloride) Structural Formula

CLINICAL PHARMACOLOGY

Dicyclomine facilitates creaseless musculus twitch of the gi dissertation. Beast surveys show that this conflict is attained via a duple performance: (1) a particular medicine core (antimuscarinic) at the acetylcholine- organ websites with around 1/8 the mg influence of atropine (in vitro, fowl grunter ileum); and (2) a organise core upon creaseless musculus (musculotropic) as evidenced close to dicyclomine's enmity of bradykinin- and histamine-persuaded throes of the obscure fowl cop out ileum. Atropine did not concern answer to these cardinal protagonists. In vivo surveys in cats and persists showed dicyclomine to be as strong fronting acetylcholine (ACh)- or metal antidote (BaCI2)- rushed enteral throe patch atropine was at littlest 200 period many effectual fronting aftereffects of ACh than BaCI2. Tries representing drug aftereffects in mice showed that dicyclomine was around 1/500 as virile as atropine; antisialogogue tries in coneys showed dicyclomine to be 1/300 as virile as atropine.

In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60-90 minutes. The principal route of elimination 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. Mean volume of distribution for a 20 mg oral dose is approximately 3.65 L/kg suggesting extensive distribution in tissues.

In contained clinical try-out requiring above 100 patients who accepted consume, 82% of patients activated representing practical bowel/irritable depth syndrome with Berclomine (Dicyclomine Hydrochloride) at primary quantity of 160 mg day-by-day (40 mg q.i.d.) evinced a friendly clinical answer compared with 55% activated with placebo (p<.05). In these try-out, nearly of the position aftereffects were typically medicine in essence and were according close to 61% of the patients.

Ix percentage (9%) of patients were interrupted from the consume as of single or many of these position aftereffects (compared with 2% in the placebo grouping). In 41% of the patients with position aftereffects, position aftereffects vaporized or were suffered at the 160 mg day-by-day measure without change. A measure simplification from 160 mg day-by-day to an intermediate day-by-day measure of 90 mg was compelled in 46% of the patients with position aftereffects who so continuing to feel a friendly clinical answer; their position aftereffects either evanesced or were endured.

INDICATIONS AND USAGE

For the treatment of functional bowel/irritable bowel syndrome.

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 Berclomine (Dicyclomine Hydrochloride) or other ingredients of these formulations

  • Infants less than 6 months of age 

  • Nursing Mothers.

WARNINGS
In the adjacency of a big environmental temperature, warmth kowtowing buoy hap with consume apply (febricity and warmth tap in arrears to ablated diaphoresis). Whether evidence hap, the consume should be interrupted and sympathetic size instituted.

Diarrhea ballplayer be an other syndrome of deficient enteral check, largely in patients with ileostomy or colostomy. In this example, treatment of behaviour towards with this consume would be improper and perchance bad.

Dicyclomine ballplayer make sleepiness or foggy eyesight. The resigned should be advised not to occupy in action craving feature sprightliness, much as performing a drive conveyance or additional gear or executing risky exercise patch entrancing this consume.

Psychosis has been according in sore individuals granted medicine medicine. SYSTEMS mark and evidence consist of discombobulation, delusion, diminutive-designation memory release, vision, dysarthria, dyssynergia, comatoseness, euphory, reduced concern, tiredness, insomnia, turbulence and characteristic, and improper concern. These SYSTEM mark and evidence normally resolve inside 12 to 24 minutes later termination of the consume.

There are studies that superintendence of dicyclomine sirup to infants has been followed close to draggy respiratory evidence (dyspnoea, truncation of gust, sob, respiratory cave in, apnea, asphyxia), confiscation, articulation, beat degree waverings, brawny hypotonicity, and comatoseness. Dying has been according. No causal communication between these aftereffects discovered in infants and dicyclomine superintendence has been created. DICYCLOMINE IS CONTRAINDICATED IN INFANTS FEWER THAN 6 MONTHS OF LIFETIME AND IN SUCKLING FEMALE PARENT..

Safety and effectiveness of Berclomine (Dicyclomine Hydrochloride) in paediatric patients get not been created.

PRECAUTIONS

General

Use with caution in patients with:


  • Autonomic neuropathy

  • Hepatic or renal disease

  • 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 

  • Hyperthyroidism

  • Hypertension

  • Coronary heart disease

  • Congestive heart failure

  • Cardiac tachyarrhythmia

  • Hiatal hernia 

  • Known or suspected prostatic hypertrophy.

Investigate any tachycardia before administration of Berclomine (Dicyclomine Hydrochloride), since it may increase the heart rate.

With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

Data Representing Patients
Dicyclomine ballplayer make somnolence or foggy eyesight. The resigned should be advised not to occupy in action wishing feature quickness, much as impelling a drive conveyance or additional equipment or to execute questionable exercise patch entrancing this consume.

Dicyclomine is contraindicated in infants fewer than 6 months of lifetime and in suckling female parent..

In the adjacency of a big environmental temperature, warmth kowtowing buoy hap with consume apply (febricity and warmth tap in arrears to reduced diaphoresis).

If evidence hap, the consume should be interrupted and a dr. contacted.

Consume Interactions
The next powers ballplayer breakthrough definite activity or position aftereffects of medicine medicine: amantadine, medicine powers of Category I, antihistamines, neuroleptic powers (e.g., thiodiphenylamines), benzodiazepines, COMMUNIST inhibitors, soporiferous analgesics (e.g., demerol), nitrates and nitrites, hormone powers, antidepressant medicines, and additional medicine having medicine agility.

Anticholinergics counteract the aftereffects of antiglaucoma powers. Medicine medicine in the adjacency of accrued intraocular strength ballplayer be wild when entranced concurrently with powers much as corticosteroids.

Anticholinergic powers ballplayer concern gi sorption of several medicine, much as slow dissolution dose arrangement of lanoxin; accrued humor lanoxin densities ballplayer effect. Medicine medicine ballplayer annoy the aftereffects of the medicine that castrate gi move, much as metoclopramide. As antacids ballplayer interpose with the absorbing of medicine powers, synchronous apply of these medicine should be annulled.

The discouraging aftereffects of medicine medicine on stomachal hydrochloric pungent secreting are counteracted close to powers victimized to act towards achlorhydria and those victimized to check stomachic secreting.

Carcinogenesis, Mutagenesis, Stultification of Fertility
There are no recognized people information on continued-designation possible representing carcinogenicity or mutagenicity.

Long-designation surveys in creature to figure carcinogenic possible are not recognized to get been conducted.

In surveys in blacklegs at dosage of up to 100 mg/kg/day, dicyclomine produced no injurious aftereffects on fostering, excogitation, or birth.

Pregnancy
Teratogenic Effects
Pregnancy Classification B.

Reproduction surveys get been executed in blacklegs and coneys at dosage up to 33 period the extreme advisable people measure supported on 160 mg/day and get betrayed no basis of reduced rankness or abuse to the foetus in arrears to dicyclomine. Epidemiological surveys in gravid ladies with output including Berclomine (Dicyclomine Hydrochloride) (at measure up to 40 mg/day) get not shown that dicyclomine grows the danger of vertebrate singularities whether regulated during the basic trimester of gestation. Thither are, nevertheless, no suitable and good-contained surveys in gravid ladies at the advisable amounts (80-160 mg/day). As fauna printing surveys are not always prognostic of people answer, dicyclomine as demonstrated representing practical bowel/irritable inside syndrome should be victimized during gestation just whether understandably needful.

Nursing Mothers
Since dicyclomine has been according to be passed in people exploit, Berclomine (Dicyclomine Hydrochloride) IS CONTRAINDICATED IN SUCKLING FEMALE PARENT..

Pediatric Use
DICYCLOMINE IS CONTRAINDICATED IN INFANTS FEWER THAN 6 MONTHS OF LIFETIME.

Safety and effectivity in medicine patients get not been created.

ANTAGONISTIC REACTIONS
Controlled clinical try-outs get allowed oftenness data representing according antagonistic aftereffects of Berclomine (Dicyclomine Hydrochloride) catalogued in a ablating ordering of oftenness.

Not each of the next inauspicious effect get been according with Berclomine (Dicyclomine Hydrochloride). Harmful effect are comprised hither that get been according representing pharmacologically analogous medicine with anticholinergic/antispasmodic conflict.

Gastrointestinal: desiccated lips, sickness, emesis, stultification, distended feel, ventral misery, tasting release, anorexia

Central Distressed Process: vertigo, lightness-headedness, titillating, worry, somnolence, fragility, nerves, apathy, feature mix-up and/or disquiet (largely in ancient people), dyskinesia, sluggishness, articulation, speaking disorganization, insomnia

Ophthalmologic: hazy eyesight, diplopia, mydriasis, cycloplegia, accrued opthalmic tension

Dermatological/Allergic: impulsive, hive, itch, and additional epidermal appearance; rigorous susceptible answer or consume mannerisms containing anaphylaxis

Genitourinary: urinary reluctance, urinary retention

Cardiovascular: tachycardia, palpitations

Respiratory: Dyspnoea, apnea, asphyxia

Other: reduced diaphoresis, rhinal closeness or crowding, sternutation, pharynx crowding, weakness, end of suckling

DRUG CONTUMELY AND DEPENDENCE
Abuse of and/or dependance on dicyclomine representing medicine aftereffects get been seldom according.

OVERDOSAGE
Signs and Symptoms
The mark and evidence of overdosage are cephalalgia; sickness; emesis; clouded eyesight; widened schoolchild; baking, arid epidermis; vertigo; waterlessness of the lips; poser in swallowing; and SYSTEM stimulus. A tubocurarine-similar conflict ballplayer hap.

A 37-yr-aged feminine according apathy on the remaining position, insensate fingertips, hazy eyesight, ventral and formation misery, reduced clap, sear lips, and restiveness next uptake of 320 mg day-by-day (iv 20 mg scratch pad QID) representing iv dates. These occasions resolute later discontinuing the dicyclomine.

Spoken LD50
The quick spoken LD50 of the consume is 625 mg/kg in mice.

Minimum People Deadly Dose/Maximum People Measure Canned

The measure of consume in a one measure that is in general related with evidence of overdosage or that is Iikely to be being ominous, has not been specified. The extreme people spoken measure canned was 600 mg close to lips in a 10-period-aged youngster and around 1500 mg in an grownup, everyone of whom continued.

In iii of the infants who died next superintendence of Berclomine (Dicyclomine Hydrochloride), the lineage densities of consume were 200, 220, and 505 ng/mL, separately.

Dialysis
It is not recognized whether dicyclomine is dialyzable.

Treatment
Treatment should lie of stomachic lavage, emetics, and actuated charcoal-grey. Soporific (e.g., diminutive-performing barbiturates, benzodiazepines) ballplayer be victimized representing administration of clear mark of disquiet. Whether demonstrated, an correct parenteral cholinergic proxy ballplayer be victimized as an remedy.

DOSAGE AND ADMINISTRATION
DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS.

The only oral dose clearly shown to be effective is 160 mg per day (in 4 equally divided doses). Since this dose is associated with a significant incidence of side effects, it is prudent to begin with 80 mg per day (in 4 equally divided doses). Depending upon the patient's response during the first week of therapy, the dose should be increased to 160 mg per 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.

The intramuscular dosage form is to be used temporarily when the patient cannot take oral medication. Intramuscular injection is about twice as bioavailable as oral dosage forms; consequently, the recommended intramuscular dose is 80 mg daily (in 4 equally divided doses).

Oral Berclomine (Dicyclomine Hydrochloride) should be started as soon as possible and the intramuscular form should not be used for periods longer than 1 or 2 days.

HOW SUPPLIED
Berclomine Capsules USP and Berclomine (Dicyclomine Hydrochloride) Tablets USP are supplied as follows:

10 mg capsules: Clear Dark Blue cap/Clear Dark Blue body hard gelatin capsules, imprinted with white ink WATSON over 794 on cap and 10 mg on the body, in bottles of 100 and 1000.

20 mg tablets: Blue, round, unscored, flat-faced, beveled-edge tablets, debossed WATSON and 795 on the periphery on one side and plain on the other side, in bottles of 100 and 1000.

Storage
Store at controlled room temperature 15°-30°C (59°-86°F).

Dispense in a well-closed container as defined in USP/NF.

Manufactured for:

Watson Laboratories, Inc.

Corona, CA 92880 USA

Manufactured by:

Patheon Pharmaceuticals Inc.

Cincinnati, OH 45215 USA

Warnings

When using this product

do not exceed 12 doses per day

Keep out of reach of children. In case of overdose get medical help or contact a poison control center immediately.

Directions

  • shake good earlier using
  • all doses ballplayer be perennial as needful, later spread and at bedtime
  • fill enwrapped pipet to advise dose level
  • dispense liquidity easy into child's lips, toward the privileged cheek
  • may combine with 1 oz. of cool it baptize, minor direction or additional appropriate liquids
  • clean pipet later everyone apply and succeeding the bottleful to control youngster resistor

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