Hydrocortisone Acetate and Pramoxine Hydrochloride

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Overview

What is Hydrocortisone Acetate and Pramoxine Hydrochloride?

DESCRIPTION:

What does Hydrocortisone Acetate and Pramoxine Hydrochloride look like?

What are the available doses of Hydrocortisone Acetate and Pramoxine Hydrochloride?

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What should I talk to my health care provider before I take Hydrocortisone Acetate and Pramoxine Hydrochloride?

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How should I use Hydrocortisone Acetate and Pramoxine Hydrochloride?

INDICATIONS AND USAGE:

DOSAGE AND ADMINISTRATION:

What interacts with Hydrocortisone Acetate and Pramoxine Hydrochloride?

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What are the warnings of Hydrocortisone Acetate and Pramoxine Hydrochloride?

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What are the precautions of Hydrocortisone Acetate and Pramoxine Hydrochloride?

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What are the side effects of Hydrocortisone Acetate and Pramoxine Hydrochloride?

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What should I look out for while using Hydrocortisone Acetate and Pramoxine Hydrochloride?

CONTRAINDICATIONS:

What might happen if I take too much Hydrocortisone Acetate and Pramoxine Hydrochloride?

OVERDOSAGE:

PRECAUTIONS

How should I store and handle Hydrocortisone Acetate and Pramoxine Hydrochloride?

Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep bottle tightly closed and protect from moisture.Hydrocortisone Acetate 2.5%-Pramoxine HCI 1 % Cream 1 ounce tube (NDC 42192-107-01) 30 x 4 gram tubes (NDC 42192-108-04) Hydrocortisone Acetate 2.5%-Pramoxine HCI 1 % Cream Kit with Pramoxine Wipes 1 ounce tube (NDC 42192-118-07) 30 x 4 gram tubes (NDC 42192-119-30) Hydrocortisone Acetate 2.5%-Pramoxine HCI 1 % Cream 1 ounce tube (NDC 42192-107-01) 30 x 4 gram tubes (NDC 42192-108-04) Hydrocortisone Acetate 2.5%-Pramoxine HCI 1 % Cream Kit with Pramoxine Wipes 1 ounce tube (NDC 42192-118-07) 30 x 4 gram tubes (NDC 42192-119-30)

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Clinical Information

Chemical Structure

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Clinical Pharmacology

CLINICAL PHARMACOLOGY:

The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.

Non-Clinical Toxicology

CONTRAINDICATIONS:

ACE-inhibitors

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Aspirin

When ibuprofen tablets are administered with aspirin, its protein binding is reduced, although the clearance of free ibuprofen tablets is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential for increased adverse effects.

Diuretics

Clinical studies, as well as post marketing observations, have shown that ibuprofen tablets can reduce the natriuretic effect-of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see , ), as well as to assure diuretic efficacy.

Lithium

Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration. This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy).

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.

Warfarin-type anticoagulants

Several short-term controlled studies failed to show that ibuprofen tablets significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on coumarin-type anticoagulants. However, because bleeding has been reported when ibuprofen tablets and other NSAIDs have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering ibuprofen tablets to patients on anticoagulants. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

H-2 Antagonists

In studies with human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations.

PRECAUTIONS: General:

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

ADVERSE REACTIONS:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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