Somazole 40 mg (Capsule (Enteric Coated))

Title

• Somazole 40 mg Capsule

Categories

• Medicine
• Healthcare
• Gastroenterology

Description

• Proton pump inhibitor for relieving chronic heartburn symptoms
• Indicated for healing erosive esophagitis and maintenance of healing
• Used in combination therapy for Helicobacter pylori eradication
• Treatment for Zollinger-Ellison Syndrome and acid-related dyspepsia
• For duodenal and gastric ulcer
• Suppresses gastric acid secretion by specific inhibition of H+/K+-ATPase
• Enteric-coated pellet formulation of esomeprazole magnesium
• Peak plasma levels occur at approximately 1.5 hours after oral administration
• Approximately 90% systemic bioavailability at repeated once daily dosing
• Esomeprazole is 97% bound to plasma proteins
• Extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system
• Plasma elimination half-life of approximately 1-1.5 hours
• No clinically relevant interactions with drugs metabolized by CYPs 1A2, 2A6, 2C9, 2D6, 2E1, and 3A4
• May interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability
• No significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin
• May potentially interfere with CYP2C19, the major Somazole metabolizing enzyme
• No change in the pharmacokinetic profile when co-administered with oral contraceptives, diazepam, phenytoin, or quinidine
• Storage at a temperature not exceeding 30°C, protected from light and moisture

Dimensions

• Capsule: 40 mg
• Oral Suspension: 15 ml
• IV Injection: 5 ml of 0.9% Sodium Chloride

Color options

• Enteric-coated

Functions

• Relieves chronic heartburn symptoms
• Heals erosive esophagitis
• Suppresses gastric acid secretion
• Eradicates Helicobacter pylori infection
• Treats Zollinger-Ellison Syndrome
• Relieves acid-related dyspepsia
• Heals duodenal and gastric ulcers

Materials

• Esomeprazole magnesium
• Enteric-coated pellet formulation

Technical specifications

• Administered orally one hour before meals
• Daily doses for healing, maintenance, symptomatic GERD, H. pylori eradication, and Zollinger-Ellison Syndrome
• Dosage adjustment for pediatric patients based on body weight
• IV Injection: >3 minutes, IV Infusion: 10-30 minutes
• IV Infusion for risk reduction of rebleeding of gastric or duodenal ulcers
• No dosage adjustment for patients with mild to moderate hepatic insufficiency
• Symptomatic and supportive treatment recommended in case of overdose

Design elements

• Clear and colorless to very slightly yellow reconstituted solution for IV injection

Usability features

• Swallowed whole for tablet or capsule administration
• Oral suspension to be taken into a glass with water
• IV injection administered over at least 3 minutes

Pregnancy lactation

• No adequate and well-controlled studies in pregnant women
• Animal studies have shown no teratogenic effects
• Excretion in milk not studied, breastfeeding should be discontinued if essential

Precautions warnings

• Symptomatic response to therapy does not preclude the presence of gastric malignancy
• Capsules should be taken at least one hour before meals
• Pellets should not be chewed or crushed when administered with applesauce
• Antacids may be used while taking Somazole

Special populations

• Safety and effectiveness not established in pediatric patients
• No overall differences in safety and efficacy between elderly and younger individuals
• No dosage adjustment recommended for patients with mild to moderate hepatic insufficiency
• Pharmacokinetics not expected to be altered in patients with renal impairment

Side effects

• Headache
• Diarrhea
• Nausea
• Flatulence
• Abdominal pain
• Constipation
• Dry mouth

Contraindications

• Known hypersensitivity to any of the formulation

Interactions

• Not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1, and 3A4
• Potential interference with CYP2C19
• No clinically significant interactions with certain drugs

Administration

• Tablet or capsule should be swallowed whole and taken one hour before a meal
• Oral suspension should be taken with water and consumed within 30 minutes
• IV injection solution prepared with 5 ml of 0.9% Sodium Chloride

Indications

• Relieves chronic heartburn symptoms and other GERD-associated symptoms
• For the healing and maintenance of erosive esophagitis
• In combination therapy for Helicobacter pylori eradication
• Treatment for Zollinger-Ellison Syndrome and acid-related dyspepsia
• Healing of duodenal and gastric ulcers

Pregnancy and lactation

• No adequate and well-controlled studies in pregnant women
• Excretion in milk not studied
• Breastfeeding should be discontinued if essential

Precautions and warnings

• Symptomatic response does not preclude the presence of gastric malignancy
• Capsules should be taken at least one hour before meals
• Antacids may be used while taking Somazole

Commonly asked questions

• Uses: Relieves chronic heartburn symptoms, heals erosive esophagitis, and more
• Side effects: Headache, diarrhea, nausea, flatulence, abdominal pain, constipation, dry mouth
• Pregnancy and breastfeeding: Talk to the doctor about risks and benefits

Overdose effects

• Toxicity signs: Reduced motor activity, changes in respiratory frequency, tremor, intermittent clonic convulsions
• No specific antidote known, symptomatic and supportive treatment recommended

Storage conditions

• Store at a temperature not exceeding 30°C
• Protect from light and moisture
• Keep out of reach of children

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