Formulex by Valeant
Formulex by Valeant Uses, Dosage, Side Effects, Food Interaction and all others data.
Dicycloverine HCl relieves smooth muscle spasm in the GI and urinary tract. This effect is partly due to antimuscarinic action and partly direct action on the smooth muscle.
Formulex by Valeant is an anticholinergic drug used to relax the smooth muscles of the intestines. It's duration of action is not especially long as it is usually taken 4 times daily with individual doses of 20-40mg orally or 10-20mg by intramuscular injection. Formulex by Valeant should not be administered intravenously.
| Trade Name | Formulex by Valeant |
| Availability | Prescription only |
| Generic | Dicyclomine |
| Dicyclomine Other Names | Dicicloverina, Dicyclomine, Dicycloverin, Dicycloverine, Dicycloverinum |
| Related Drugs | Bentyl, hyoscyamine, Amitiza, Metamucil, psyllium, Lotronex |
| Type | |
| Formula | C19H35NO2 |
| Weight | Average: 309.4867 Monoisotopic: 309.266779369 |
| Protein binding | Data regarding plasma protein binding of dicyclomine is not readily available. |
| Groups | Approved |
| Therapeutic Class | Anticholinergics (antimuscarinics)/ Anti-spasmodics |
| Manufacturer | |
| Available Country | Canada, United States |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Dicycloverine is used for:
- Functional bowel/ irritable bowel syndrome
- Urinary incontinence secondary to unstable detrusor muscle
- Infantile colic
- GIT spasm
- Colicky abdominal pain
- Diverticulitis
- Abdominal colic
Formulex by Valeant is also used to associated treatment for these conditions: Functional bowel syndrome, Irritable Bowel Syndrome (IBS), Gastrointestinal cramps caused by Gas
How Formulex by Valeant works
Formulex by Valeant achieves its action partially through direct antimuscarinic activity of the M1, M3, and M2 receptors; and partially through antagonism of bradykinin and histamine. Formulex by Valeant non-competitively inhibits the action of bradykinin and histamine, resulting in direct action on the smooth muscle, and decreased strength of contractions seen in spasms of the ileum.
Dosage
Formulex by Valeant dosage
Oral dosage forms-
- Adults:10 to 20 mg three times a day.
- Children >6 months of age: 5 to 10 mg three times a day.
- Children <6 months of age: Dose must be determined by the doctor.
Oral dicycloverine Hydrochloride should be started as soon as possible
Intramuscular dosage form
- Adults:Intramuscular injection. Not for intravenous use. The recommended intramuscular dose is 80 mg daily (in 4 equally divided doses).
Intramuscular dosage form should not be used for periods longer than 1 or 2 days.
Side Effects
Insomnia, mydriasis, cycloplegia, increased ocular tension, urinary hesitancy, palpitations, dyspnea.
Toxicity
Patients experiencing an overdose may present with headache, nausea, vomiting, blurred vision, dilated pupils, dizziness, dry mouth, difficulty swallowing, CNS stimulation, as well as hot, dry skin. Treat patients with gastric lavage, emetics, activated charcoal, sedatives for excitement, and a cholinergic agent if indicated.
The oral LD50 in mice is 625mg/kg.
Precaution
Use with caution in patients with autonomic neuropathy, hepatic or renal disease, ulcerative colitis, coronary heart disease, congestive heart failure, cardiac tachyarrhythmia, known or suspected prostatic hypertrophy.
Interaction
The following agents may increase certain actions or side-effects of Dicycloverine-antiarrhythmic agents, antihistamines, antipsychotic agents, benzodiazepines, MAO inhibitors, narcotic analgesics, nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants and other drugs having anticholinergic activity.
Food Interaction
- Avoid alcohol. Alcohol may increase drowsiness caused by dicyclomine.
- Drink plenty of fluids. Formulex by Valeant may reduce sweating, increasing the risk of overheating in warm weather or during exercise.
Formulex by Valeant Alcohol interaction
[Moderate] GENERALLY AVOID:
Use of anticholinergic agents with alcohol may result in sufficient impairment of attention so as to render driving and operating machinery more hazardous.
In addition, the potential for abuse may be increased with the combination.
The mechanism of interaction is not established but may involve additive depressant effects on the central nervous system.
No effect of oral propantheline or atropine on blood alcohol levels was observed in healthy volunteers when administered before ingestion of a standard ethanol load.
However, one study found impairment of attention in subjects given atropine 0.5 mg or glycopyrrolate 1 mg in combination with alcohol.
Alcohol should generally be avoided during therapy with anticholinergic agents.
Patients should be counseled to avoid activities requiring mental alertness until they know how these agents affect them.
Formulex by Valeant Hypertension interaction
[Minor] Cardiovascular effects of anticholinergics may exacerbate hypertension.
Therapy with anticholinergic agents should be administered cautiously in patients with hypertension.
Formulex by Valeant Drug Interaction
Moderate: diphenhydramine, diphenhydramineMinor: acetaminophen, acetaminophenUnknown: duloxetine, duloxetine, omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids, pregabalin, pregabalin, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol, alprazolam, alprazolam, cetirizine, cetirizine
Formulex by Valeant Disease Interaction
Major: autonomic neuropathy, GI obstruction, glaucoma, obstructive uropathy, tardive dyskinesia, myasthenia gravis, infectious diarrhea, CV acute hemorrhage, reflux esophagitis., severe ulcerative colitisModerate: coronary artery disease, gastroesophageal reflux, psychoses, hepatic impairment, hyperthyroidism, renal impairmentMinor: hypertension, fever
Volume of Distribution
The volume of distribution for a 20mg oral dose is 3.65L/kg.
Elimination Route
The bioavailability of dicyclomine has not been determined, though it is likely well absorbed as the primary route of elimination is in the urine. Formulex by Valeant has a Tmax of 1-1.5h.
Half Life
The mean plasma elimination half life is approximately 1.8 hours.
Clearance
Data regarding the clearance of dicyclomine is not readily available.
Elimination Route
Formulex by Valeant is 79.5% eliminated in the urine and 8.4% in the feces.
Pregnancy & Breastfeeding use
Pregnancy: Category B. Dicycloverine was neither teratogenic nor embryocidal in animal trial. It, like other drugs should be used during pregnancy only if clearly needed. There are no data on the secretion of this drug into breast milk. Dicycloverine should be used cautiously in case of lactating mother.
Contraindication
Dicycloverine is contraindicated in:
- 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 dicycloverine hydrochloride or other ingredients of this formulation
- Infants less than 6 months of age
Acute Overdose
Toxic reaction seldom occurs with dicycloverine. The signs and symptoms of overdosage are headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation.
Storage Condition
Store below 30°C.
Innovators Monograph
You find simplified version here Formulex by Valeant
Formulex by Valeant contains Dicyclomine see full prescribing information from innovator Formulex by Valeant Monograph, Formulex by Valeant MSDS, Formulex by Valeant FDA label
FAQ
What is Formulex by Valeant used for?
Formulex by Valeant is used to treat a certain type of intestinal problem called irritable bowel syndrome. It helps to reduce the symptoms of stomach and intestinal cramping. Formulex by Valeant is a medication that is used to treat spasms of the intestines such as occur in irritable bowel syndrome.
How does Formulex by Valeant work?
Formulex by Valeant works by slowing the natural movements of the gut and by relaxing the muscles in the stomach and intestines.
How safe is Formulex by Valeant?
Formulex by Valeant may increase your risk of developing heat stroke in hot weather because it decreases your ability to sweat.
What are the common side effects of Formulex by Valeant?
Common sid effects of Formulex by Valeant are Dizziness, drowsiness, lightheadedness, weakness, blurred vision, dry eyes, dry mouth, nausea, constipation, and abdominal bloating. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Is Formulex by Valeant safe during pregnancy?
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. This Formulex by Valeant should be used during pregnancy only if clearly needed.
Is Formulex by Valeant safe during breastfeeding?
Formulex by Valeant has not been well studied during breastfeeding. However, one possible case of apnea has been reported in a breastfed infant that is similar to reactions that have occurred in infants given the drug directly. Formulex by Valeant should not be used during lactation.
Can I drink alcohol with Formulex by Valeant?
Alcohol may increase drowsiness and dizziness while you are taking Formulex by Valeant. You should be warned not to exceed recommended dosages and to avoid activities requiring mental alertness.
Can I drive after taking Formulex by Valeant?
Formulex by Valeant oral tablet may cause drowsiness. You shouldn't do anything that requires you to be mentally alert, such as driving or operating machinery, until you know how this drug affects you.
When should be taken of Formulex by Valeant?
Usually, Formulex by Valeant is taken before meals and at bedtime or as directed by your provider. You should follow all the instructions exactly as prescribed.
How many time can I take Formulex by Valeant daily?
You should take Formulex by Valeant four times a day by mouth.
How much Formulex by Valeant can I take daily?
The typical starting dose is 20 mg, taken four times per day. After 1 week, your doctor may increase your dose to 40 mg, taken four times per day. The maximum dose is 40 mg, taken four times per day.
How long does Formulex by Valeant take to work?
Formulex by Valeant starts working within 1 to 2 hours, but it needs to be taken four times a day.
How long does Formulex by Valeant last?
It usually works extremely well, if taken at least 2-3 hours in advance. Its effects seem to last for up to 10 hours. Sometimes I take it in conjunction with.
How long can I stay on Formulex by Valeant?
Formulex by Valeant should only be used short term. If your symptoms do not improve after 2 weeks, you should contact your healthcare provider for other alternatives.
Who should not take Formulex by Valeant?
Older adults should not usually take Formulex by Valeant because it is not as safe or effective as other medications that can be used to treat the same condition.
What happens if I overdose?
Seek emergency medical attention. Overdose can cause nausea, vomiting, dilated pupils, weakness or loss of movement in any part of your body, trouble swallowing, fainting, or seizure (convulsions).
What happens if I miss a dose?
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
What happen If I stop taking Formulex by Valeant?
If you stop taking the Formulex by Valeant suddenly or don't take it at all: The spasms in your intestines may not get better or may get worse.
Can Formulex by Valeant affects my heart ?
Formulex by Valeant may cause a rapid or abnormal heart rate. The risk of this side effect is increased if you already have an abnormal or rapid heart rate, congestive heart failure, or history of heart attack or uncontrolled blood pressure.
Can Formulex by Valeant affect my kidneys?
Formulex by Valeant 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. Formulex by Valeant should be administered with caution in patients with renal impairment.
Can Formulex by Valeant affects my liver?
Formulex by Valeant has not been implicated in causing liver enzyme elevations or clinically apparent acute liver injury.
