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Generic Name
Atorvastatin
Brand Names
Dicyclomine, Amlodipine Besylate, Amlodipine, Sdamlo, Olmesartan Medoxomil, Benazepril, Caduet, Azor, Tribenzor, Atorvaliq, Katerzia, Benicar, Lotrel, Olmesartan Medoxomil Amlodipine, Lipitor, Norliqva, Norvasc, Lotensin
FDA approval date: September 30, 1974
Classification: HMG-CoA Reductase Inhibitor
Form: Injection, Tablet, Suspension, Capsule, Solution
What is Dicyclomine (Atorvastatin)?
Atorvastatin calcium tablets are indicated: To reduce the risk of: Myocardial infarction , stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia . As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia . As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia Atorvastatin calcium is an HMG-CoA reductase inhibitor indicated : To reduce the risk of: Myocardial infarction , stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease but without clinically evident CHD. MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia . As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia. As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.
Approved To Treat
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Brand Information
Dicyclomine hydrochloride (Dicyclomine hydrochloride)
1INDICATIONS AND USAGE
Dicyclomine hydrochloride capsules, USP are indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
2DOSAGE AND ADMINISTRATION
Dosage must be adjusted to individual patient needs.
2.1Oral Dosage and Administration in Adults
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.
3DOSAGE FORMS AND STRENGTHS
Dicyclomine hydrochloride capsules, USP 10 mg: Blue/Blue Capsule Printed; "West-ward 3126" in White Ink
4CONTRAINDICATIONS
Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age
- unstable cardiovascular status in acute hemorrhage
- myasthenia gravis
- glaucoma
- obstructive uropathy
- obstructive disease of the gastrointestinal tract
- severe ulcerative colitis
- reflux esophagitis
5ADVERSE REACTIONS
The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors
The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms
5.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure in controlled clinical trials involving over 100 patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times a day).
In these trials most of the side effects were typically anticholinergic in nature and were reported by 61% of the patients. Table 1 presents adverse reactions (
Table 1: Adverse reactions experienced in controlled clinical trials with decreasing order of frequency
Nine percent (9%) of patients were discontinued from dicyclomine hydrochloride because of one or more of these side effects (compared with 2% in the placebo group). In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction. A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated.
5.2Postmarketing Experience
The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of dicyclomine hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Cardiac Disorders:palpitations, tachyarrhythmias
- Eye Disorders:cycloplegia, mydriasis, vision blurred
- Gastrointestinal Disorders:abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, nausea, vomiting
- General Disorders and Administration Site Conditions:fatigue, malaise
- Immune System Disorders:drug hypersensitivity including face edema, angioedema, anaphylactic shock
- Nervous System Disorders:dizziness, headache, somnolence, syncope
- Psychiatric Disorders:As with the other anticholinergic drugs, cases of delirium or symptoms of delirium such as amnesia (or transient global amnesia), agitation, confusional state, delusion, disorientation, hallucination (including visual hallucination) as well as mania, mood altered and pseudodementia, have been reported with the use of dicyclomine. Nervousness and insomnia have also been reported.
- Reproductive System and Breast Disorders:suppressed lactation
- Respiratory, Thoracic and Mediastinal Disorders:dyspnoea, nasal congestion
- Skin and Subcutaneous Tissue Disorder:dermatitis allergic, erythema, rash
5.3Adverse Reactions Reported with Similar Drugs with Anticholinergic/Antispasmodic Action
Gastrointestinal:anorexia
Central Nervous System:tingling, numbness, dyskinesia, speech disturbance, insomnia
Peripheral Nervous System:With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis)
Ophthalmologic:diplopia, increased ocular tension
Dermatologic/Allergic:urticaria, itching, and other dermal manifestations
Genitourinary:urinary hesitancy, urinary retention in patients with prostatic hypertrophy
Cardiovascular:hypertension
Respiratory:apnea
Other:decreased sweating, sneezing, throat congestion, impotence.
To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or
6OVERDOSAGE
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 LD
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.
7DESCRIPTION
Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available as:
Dicyclomine hydrochloride capsules, USP for oral use containing 10 mg dicyclomine hydrochloride, USP. Dicyclomine hydrochloride 10 mg capsules contain the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Capsule shells contain FD&C Blue No.1, FD&C Red No.40, gelatin, purified water, and sodium lauryl sulfate. The white monogramming ink contains: ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac, simethicone, and titanium dioxide.
Dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C
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.
8CLINICAL STUDIES
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).
9HOW SUPPLIED/STORAGE AND HANDLING
Dicyclomine hydrochloride capsules, USP 10 mg are supplied as Blue/Blue Capsule Printed “West-ward 3126” in White Ink and are available in:
Bottles of 100 capsules NDC 51407-783-01
Bottles of 1000 capsules NDC 51407-783-10
Store at 20° to 25°C (68° to 77°F). [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.
10PRINCIPAL DISPLAY PANEL
NDC 51407-783-01
