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Arnicare

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Uses

Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for:

1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)

Pantoprazole Sodium Delayed-Release Tablet, USP is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.

1.2 Maintenance of Healing of Erosive Esophagitis

Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.

1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

Pantoprazole Sodium Delayed-Release Tablets USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

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History

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Other Information

The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP is a substituted benzimidazole, 5-(Difluoromethoxy) -2- [[(3,4 dimethoxy-2- pyridyl)methyl] sulfinyl]benzimidazole, sodium salt, sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S . 1.5 H2O, with a molecular weight of 432.4. The structural formula is:

structure.jpg

Pantoprazole sodium sesquihydrate, USP is a white to off-white powder. Pantoprazole sodium sesquihydrate, USP is freely soluble in water, in methanol, in dehydrated alcohol, practically insoluble in hexane and dichloromethane.

The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.

Pantoprazole Sodium is supplied as a Delayed-Release Tablet, available in two strengths (20 mg and 40 mg).

Each Pantoprazole Sodium Delayed-Release Tablet, USP contains 45.11 mg or 22.55 mg of pantoprazole sodium sesquihydrate, USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, ferric oxide yellow, hydroxy propyl cellulose, hypromellose, lactose monohydrate, methacrylic acid copolymer, polysorbate 80, propylene glycol, sodium carbonate anhydrous, sodium lauryl sulfate, titanium dioxide and triethyl citrate. The tablets are imprinted with opacode black containing ammonium hydroxide, iron oxide black, propylene glycol and shellac. Pantoprazole Sodium Delayed-Release Tablets, (40 mg and 20 mg) complies with USP dissolution test 2.

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  • Laboratoires Boiron
    Arnicare | Camber Pharmaceuticals, Inc.
    No Recall

    Arnicare | Camber Pharmaceuticals, Inc.

    Arnicare | Camber Pharmaceuticals, Inc.
    2.1 Recommended Dosing Schedule

    Pantoprazole Sodium is supplied as Delayed-Release Tablets. The recommended dosages are outlined in Table 1.


    Table 1: Recommended Dosing Schedule for

    Pantoprazole SodiumDelayed-Release Tablets

    Indication Dose
    Frequency
    Short-Term Treatment of Erosive Esophagitis Associated With GERD
        Adults                                                      40 mg            Once daily for up to 8 weeks*
    Children (5 years and older)
      ≥ 15 kg to < 40 kg                                 20 mg             Once daily for up to 8 weeks
    ≥ 40 kg                                                      40 mg
     Maintenanceof Healing of Erosive Esophagitis
      Adults                                                     40 mg                Once daily
     
     PathologicalHypersecretory Conditions Including Zollinger-Ellison Syndrome
     Adults                                                      40 mg            Twice daily **

     * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered.

    ** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.
    ***Controlled studies did not extend beyond 12 months

    2.2 Administration Instructions

    Directions for method of administration for each dosage form are presented in Table 2.

    Table 2: Administration Instructions

    Formulation
    Route
    Instructions*
    Delayed-Release Tablets
        Oral
    Swallowed whole, with or without food

    * Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushed.

    Pantoprazole Sodium Delayed-Release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of Pantoprazole Sodium Delayed-Release Tablets.

  • Laboratoires Boiron
    Arnicare | Laboratoires Boiron
    No Recall

    Arnicare | Laboratoires Boiron

    Arnicare | Laboratoires Boiron

    Apply a thin layer of Arnicare Gel to the affected area as soon as possible after minor injury. Repeat 3 times a day or as needed.

  • Laboratoires Boiron
    Arnicare | Pd-rx Pharmaceuticals, Inc.
    No Recall

    Arnicare | Pd-rx Pharmaceuticals, Inc.

    Arnicare | Pd-rx Pharmaceuticals, Inc.
    2.1 Adults

    The usual initial antihypertensive oral dose of Amlodipine besylate tablets,USP  is 5 mg once daily, and the maximum dose is 10 mg once daily.

    Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding Amlodipine besylate tablets,USP  to other antihypertensive therapy.

    Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.

    Angina: The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect.

    Coronary artery disease: The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg [see Clinical Studies (14.4)].

    2.2 Children


    The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients [see Clinical Pharmacology (12.4), Clinical Studies (14.1)].

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