Spasfiz Pead

Spasfiz Pead 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.

Dicyclomine 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. Dicyclomine should not be administered intravenously.

Simethicone is used as an antiflatulent to relieve symptoms commonly referred to gas including upper GI bloating, pressure, fullness or stuffed feeling. The clinical use of Simeticone is based on its antifoaming properties. Its antifoaming action relieves flatulence by dispersing and preventing the formation of mucous surrounded gas pockets in the GI tract. Simeticone acts in the stomach and intestines to change the surface tension of gas bubbles, enabling them to coalesce; thus gas is freed and eliminated more easily by belching or passing flatus. Simeticone aids in the elimination of gas from the GI tract and can be used to reduce postoperative gas pains. Simeticone can also be used prior to gastroscopy to enhance visualization and prior to radiography of the intestine to reduce gas shadows.

Simethicone decreases the surface tension of gas bubbles in the gastrointestinal tract, facilitating their expulsion. It has a short duration of action as it is generally given as needed, and a wide therapeutic index as it is not systemically absorbed.

Trade Name Spasfiz Pead
Generic Dicyclomine + Simethicone
Type Drops
Therapeutic Class
Manufacturer Ranbaxy Laboratories (sun Pharma)
Available Country India
Last Updated: September 19, 2023 at 7:00 am
Spasfiz Pead
Spasfiz Pead

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

Flatulence, abdominal distention, fullness, gas and windy colic: Simethicone is an excellent and effective antiflatulent. It is used for relief of the painful symptoms of excess gas in the digestive tract. Such gas is frequently caused by excessive swallowing of air or by eating foods that disagree. Simethicone drop is especially used in infants, acts in the stomach and intestines. Thus Simethicone enables freeing and eliminating the gas more easily by belching or passing flatus.

Large bowel preparation: Addition of Simethicone to a polyethylene glycol bowel preparation produces symptomatic improvement prior to investigation in the management of accidental ingestion of foaming detergents.

Treatment of poisoning: Simethicone has an anecdotal use as an antifoaming agent in the management of accidental ingestion of foaming detergents.

Spasfiz Pead is also used to associated treatment for these conditions: Functional bowel syndrome, Irritable Bowel Syndrome (IBS), Gastrointestinal cramps caused by GasAbdominal Cramping, Abdominal Pain, Abdominal distension, Acid Reflux, Bloating, Colic, Diarrhoea, Distention, Dyspepsia, Flatulence, Gastric Ulcer, Gastritis, Heartburn, Hiatus Hernia, Hyperacidity, Pain, Pancreatic Insufficiency, Peptic Esophagitis, Peptic Ulcer, Stomach ache, Gastrointestinal cramps, Gastrointestinal cramps caused by Gas, Gastrointestinal spasms, Stomach cramps, Antacid therapy, Bowel preparation therapy

How Spasfiz Pead works

Dicyclomine achieves its action partially through direct antimuscarinic activity of the M1, M3, and M2 receptors; and partially through antagonism of bradykinin and histamine. Dicyclomine 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.

Simethicone is a surfactant that decreases the surface tension of gas bubbles in the gastrointestinal tract, more easily allowing gas to exit the body.

Dosage

Spasfiz Pead 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.

Take after meals and at bedtime. Can be given with infant’s feeds. Shake the bottle well before each use.

  • Children less than 2 years of age: 20 mg (0.3 ml Simethicone Paediatric Drops) 4 times daily up to 240 mg/day (3.6 ml Simethicone Paediatric Drops).
  • Children 2-12 years of age: 40 mg (0.6 ml Simethicone Paediatric Drops) 4 times daily.
  • Adults: 40-125 mg or 1-3 Simethicone chewable tablets; 4 times daily, up to 500 mg/day (12 Simethicone chewable tablets).

Side Effects

Insomnia, mydriasis, cycloplegia, increased ocular tension, urinary hesitancy, palpitations, dyspnea.

Simethicone is physiologically inert and no adverse effect has been noted after oral ingestion.

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.

Data regarding overdoses with simethicone are rare due to the fact that it is not systemically absorbed.. In the case of an overdose stop the drug and initiate symptomatic and supportive care.

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.

Do not exceed 12 doses per day except under the advice and supervision of a physician.

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.

There is no evidence that Simethicone modifies the effect of other drugs. The defoaming effect of Simethicone is reduced by antacids such as Aluminium Hydroxide and Magnesium Carbonate, which absorb the Silicone.

Volume of Distribution

The volume of distribution for a 20mg oral dose is 3.65L/kg.

Simethicone is not systemically absorbed and so these data are not readily available.

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. Dicyclomine has a Tmax of 1-1.5h.

Simethicone is not systemically absorbed and so these data are not readily available.

Half Life

The mean plasma elimination half life is approximately 1.8 hours.

Simethicone is not systemically absorbed and so these data are not readily available.

Clearance

Data regarding the clearance of dicyclomine is not readily available.

Simethicone is not systemically absorbed and so these data are not readily available.

Elimination Route

Dicyclomine is 79.5% eliminated in the urine and 8.4% in the feces.

Simethicone is eliminated 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.

Pregnant women: No data are available to suggest any harmful effects.

Lactating mother: Excretion of simethicone in breast milk has not been established, and would be most unlikely.

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.

Should be stored in cool and dry place, protected from light. Keep the medicine out of the reach of children.

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