Diltiazem Hydrochlorideextended Release Extended Release label

Diltiazem Hydrochlorideextended Release Extended Release

Diltiazem Hydrochlorideextended Release Extended Release Recall

Get an alert when a recall is issued.

Side Effects & Adverse Reactions

Warnings

Stop use and ask a doctor if:

  • symptoms persist for more than 7 days or worsen
  • inflammation, fever or infection develops
  • symptoms are acccompanied by a high fever (101°F)

If pregnant or breast-feeding, ask a health professional before use.

Do not use if imprinted tamper band is broken or missing.

In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland’s may be contacted for emergency information about our products 24 hours a day, 7 days a week at 800-624-9659.

label

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Uses

Temporarily relieves the symptoms of the common cold.

LABEL

History

There is currently no drug history available for this drug.

Other Information

There are no additional details available for this product.

Diltiazem Hydrochlorideextended Release Extended Release Manufacturers

  • Remedyrepack Inc.
    Diltiazem Hydrochlorideextended Release Extended Release | Hylands
    No Recall

    Diltiazem Hydrochlorideextended Release Extended Release | Hylands

    Diltiazem Hydrochlorideextended Release Extended Release | Hylands

    Directions

    Adults and children 12 years and over:

    dissolve 2-3 tablets under tongue every 4 hours or as needed.

    Children 6-12 years:

    half adult dose.

  • Remedyrepack Inc.
    Diltiazem Hydrochlorideextended Release Extended Release | Remedyrepack Inc.
    No Recall

    Diltiazem Hydrochlorideextended Release Extended Release | Remedyrepack Inc.

    Diltiazem Hydrochlorideextended Release Extended Release | Remedyrepack Inc.

    Patients controlled on diltiazem alone or in combination with other medications may be switched to Diltiazem Hydrochloride Extended-Release Capsules, USP at the nearest equivalent total daily dose. Higher doses of diltiazem hydrochloride extended-release capsules may be needed in some patients. Patients should be closely monitored. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.

    Hypertension: Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily.

    Angina: Dosages for the treatment of angina should be adjusted to each patient’s needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7- to 14-day period.

    Concomitant Use With Other Cardiovascular Agents

    Sublingual NTG - May be taken as required to abort acute anginal attacks during diltiazem hydrochloride extended-release capsules therapy.
    Prophylactic Nitrate Therapy - Diltiazem hydrochloride extended-release capsules may be safely coadministered with short-and long-acting nitrates.
    Beta-Blockers - (See WARNINGS and PRECAUTIONS).
    Antihypertensives - Diltiazem hydrochloride extended-release capsules have an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride extended-release capsules or the concomitant antihypertensives may need to be adjusted when adding one to the other.

     

  • Remedyrepack Inc.
    Diltiazem Hydrochlorideextended Release Extended Release | Remedyrepack Inc.
    No Recall

    Diltiazem Hydrochlorideextended Release Extended Release | Remedyrepack Inc.

    Diltiazem Hydrochlorideextended Release Extended Release | Remedyrepack Inc.

    Patients controlled on diltiazem alone or in combination with other medications may be switched to Diltiazem Hydrochloride Extended-Release Capsules, USP at the nearest equivalent total daily dose. Higher doses of diltiazem hydrochloride extended-release capsules may be needed in some patients. Patients should be closely monitored. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.

    Hypertension: Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily.

    Angina: Dosages for the treatment of angina should be adjusted to each patient’s needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7- to 14-day period.

    Concomitant Use With Other Cardiovascular Agents

    Sublingual NTG - May be taken as required to abort acute anginal attacks during diltiazem hydrochloride extended-release capsules therapy.
    Prophylactic Nitrate Therapy - Diltiazem hydrochloride extended-release capsules may be safely coadministered with short-and long-acting nitrates.
    Beta-Blockers - (See WARNINGS and PRECAUTIONS).
    Antihypertensives - Diltiazem hydrochloride extended-release capsules have an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride extended-release capsules or the concomitant antihypertensives may need to be adjusted when adding one to the other.

     

  • Remedyrepack Inc.
    Diltiazem Hydrochlorideextended Release Extended Release | Remedyrepack Inc.
    No Recall

    Diltiazem Hydrochlorideextended Release Extended Release | Remedyrepack Inc.

    Diltiazem Hydrochlorideextended Release Extended Release | Remedyrepack Inc.

    Patients controlled on diltiazem alone or in combination with other medications may be switched to Diltiazem Hydrochloride Extended-Release Capsules, USP at the nearest equivalent total daily dose. Higher doses of diltiazem hydrochloride extended-release capsules may be needed in some patients. Patients should be closely monitored. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.

    Hypertension: Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily.

    Angina: Dosages for the treatment of angina should be adjusted to each patient’s needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7- to 14-day period.

    Concomitant Use With Other Cardiovascular Agents

    Sublingual NTG - May be taken as required to abort acute anginal attacks during diltiazem hydrochloride extended-release capsules therapy.
    Prophylactic Nitrate Therapy - Diltiazem hydrochloride extended-release capsules may be safely coadministered with short-and long-acting nitrates.
    Beta-Blockers - (See WARNINGS and PRECAUTIONS).
    Antihypertensives - Diltiazem hydrochloride extended-release capsules have an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride extended-release capsules or the concomitant antihypertensives may need to be adjusted when adding one to the other.