Cyclop

A muscarinic antagonist used as an antispasmodic and in urinary incontinence. It has little effect on glandular secretion or the cardiovascular system. It does have some local anesthetic properties and is used in gastrointestinal, biliary, and urinary tract spasms.

Dysmennorhoea,colics, spasmodic pain.

Treatment of the symptoms of irritable bowel syndrome. It may also be used for other conditions as determined by your doctor.

Cyclop is an anticholinergic. It works by blocking a chemical in the smooth muscle of the stomach and intestines causing them to relax, which reduces cramping.

1 tab bid/tid.

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What is the most important information I should know about Cyclop?

Cyclop is contraindicated in infants less than 6 months of age, nursing mothers, and in patients with:

• unstable cardiovascular status in acute hemorrhage
• myasthenia gravis
• glaucoma
• obstructive uropathy
• obstructive disease of the gastrointestinal tract
• severe ulcerative colitis
• reflux esophagitis

Use Cyclop as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cyclop is usually given as an injection at your doctors office, hospital, or clinic. If you will be using Cyclop at home, a health care provider will teach you how to use it. Be sure you understand how to use Cyclop. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Cyclop is for intramuscular (IM) injection only. It is NOT for intravenous (IV) use.
• Do not use Cyclop if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• The injection form of Cyclop is only given short-term when the oral form cannot be taken. Your health care provider will prescribe the oral form of Cyclop as soon as you are able to take it.
• Use Cyclop on a regular schedule around the clock, unless your doctor tells you otherwise.
• If you miss a dose of Cyclop, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cyclop.

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What other drugs will affect Cyclop?

Antiglaucoma Agents

Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. Use of Cyclop in patients with glaucoma is not recommended.

Other Drugs With Anticholinergic Activity

The following agents may increase certain actions or side effects of anticholinergic drugs including Cyclop: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity.

Other Gastrointestinal Motility Drugs

Interaction with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide.

Effect Of Antacids

Because antacids may interfere with the absorption of anticholinergic agents including Cyclop, simultaneous use of these drugs should be avoided.

Effect On Absorption Of Other Drugs

Anticholinergic agents may affect gastrointestinal absorption of various drugs by affecting gastrointestinal motility, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result.

Effect On Gastric Acid Secretion

The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.

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What are the possible side effects of Cyclop?

The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors. 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.

Clinical 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 (MedDRA 13.0 preferred terms) by decreasing order of frequency in a side-by-side comparison with placebo.

Table 1: Adverse reactions experienced in controlled clinical trials with decreasing order of frequency

Nine percent (9%) of patients were discontinued from Cyclop 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.

Postmarketing Experience

The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of Cyclop. 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 anti-cholinergic 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

Cases of thrombosis, thrombophlebitis and injection site reactions such as local pain, edema, skin color change and even reflex sympathetic dystrophy syndrome have been reported following inadverent IV injection of Cyclop.

Adverse 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. With the injectable form, there may be temporary sensation of light-headedness. Some local irritation and focal coagulation necrosis may occur following the intramuscular injection of Cyclop.