| |
ERACID-D: |
| |
 |
| |
|
|
|
| |
|
|
 |
| |
|
|
|
| |
|
|
Composition |
| |
|
|
|
| |
|
|
Each capsule of ERACID-D contains:
Pantoprazole … 40 mg
(as enteric coated pellets)
Domperidone … 30 mg
(as sustained release pellets) |
| |
|
|
|
| |
|
|
|
| |
|
|
Therapeutic Indications & Usage |
| |
|
|
|
| |
|
|
ERACID-D is primarily advocated for managing symptom of burning in various acid peptic disorders associated with nausea and / or vomiting. It is indicated for GERD, reflux esophagitis, nonulcer dyspepsia, gastroparesis and idiopathic hiccup, or any other acid-peptic disease accompanied by nausea and / or vomiting like acute gastritis including that induced by nonsteroidal anti-inflammatory drugs (NSAIDs).
|
| |
|
|
|
| |
|
|
|
| |
|
|
Contraindications |
| |
|
|
|
| |
|
|
ERACID-D is not advocated to those hypersensitive to any of its ingredients, or to substituted benzimidazoles. |
| |
|
|
|
| |
|
|
|
| |
|
|
Precautions & Warnings |
| |
|
|
|
| |
|
|
ERACID-D should be used during pregnancy and lactation only if the potential benefit justifies the probable risks involved. In view of likelihood of pantoprazole to be excreted in human milk, and because of potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or ERACID-D, taking into account the importance of therapy to the mother. Safety and efficacy of ERACID-D ingredients in children have not been established.
|
| |
|
|
|
| |
|
|
Symptomatic response to pantoprazole (in ERACID-D) does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with pantoprazole (in ERACID-D).
|
| |
|
|
|
| |
|
|
Pantoprazole (in ERACID-D), like other proton pump inhibitors has potential to cause gastric carcinoids but the studies have not been conclusive. |
| |
|
|
|
| |
|
|
|
| |
|
|
Adverse Reactions |
| |
|
|
|
| |
|
|
Domperidone (in ERACID-D) occasionally causes dry mouth, hypersensitivity, headache, thirst, diarrhea and, rarely, nervousness. Galactorrhea and gynecomastia can also infrequently occur due to domperidone (in ERACID-D).
|
| |
|
|
|
| |
|
|
The most common adverse reactions reported with pantoprazole (in ERACID-D) are anxiety, arthralgia, asthenia, back pain, bronchitis, chest pain, constipation,increased cough, dizziness, dyspepsia, dyspnea, flu syndrome, gastroenteritis, gastrointestinal disorders, hyperlipemia, hypertonia, infection, liver function tests abnormalities (SGPT increased), migraine, nausea, neck pain, pain, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, urinary frequency, urinary tract infection.
|
| |
|
|
|
| |
|
|
Other events reported (with pantoprazole in ERACID-D) , with an incidence of less than 1%, are allergic reactions, edema, abscess, fever, cyst, malaise, photosensitivity reactions, heat stroke, dehy-dration,thirst, weight gain / loss, hernia, moniliasis, cardiovascular abnormalities, digestive complaints & liver dysfunction, diabetes mellitus, glycosuria, goiter, musculoskeletal infections, respiratory manfestations, skin lesions, urogenital disorders, taste perversion and eye and ear affections. |
| |
|
|
|
| |
|
|
|
| |
|
|
Drug Interaction |
| |
|
|
|
| |
|
|
Since pantoprazole (in ERACID-D) inhibits gastric acid secretion, it could interfere with absorption of drugs where gastric pH is an important determinant of bioavailability like ketoconazole, ampicillin esters.
|
| |
|
|
|
| |
|
|
|
| |
|
|
Recommended Dosage & Administration |
| |
|
|
|
| |
|
|
Adults: One ERACID-D Capsule once or twice daily 15 minutes before food, for 4-12 weeks, or as prescribed. |
| |
|
|
|
| |
|
|
Maintenance Therapy: One ERACID-D Capsule once daily 15 minutes before breakfast to prevent recurrence in patients with reflux esophagitis, or as prescribed. |
| |
|
|
|
| |
|
|
|
| |
|
|
Presentation |
| |
|
|
|
| |
|
|
ERACID-D Capsules: Blisters of 10s. |
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
|
| |
|
|
|
|
|
