DOXY Powder for solution for injection (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Fresenius Kabi USA, LLC

Λέξεις κλειδιά

63323-130

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1. Description

Doxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, ascorbic acid and mannitol in Water for Injection. Doxycycline hyclate is a broad spectrum ...

2. Clinical Pharmacology

Tetracyclines are readily absorbed and are bound to plasma proteins in varying degree. They are concentrated by the liver in the bile, and excreted in the urine and feces at high concentrations and in ...

3. Indications and Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline for Injection, USP and other antibacterial drugs, Doxycycline for Injection, USP should be used only to ...

4. Contraindications

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

5. Warnings

The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). ...

6.1. General

As with other antibacterial drugs, use of doxycycline may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, doxycycline should be discontinued and appropriate ...

6.2. Information for Patients

Patients taking doxycycline should be advised: to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue therapy if phototoxicity (e.g., skin eruption, ...

6.3. Laboratory Tests

In venereal diseases when coexistent syphilis is suspected, a dark field examination should be done before treatment is started and the blood serology repeated monthly for at least 4 months. In long-term ...

6.4. Drug Interactions

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacteriostatic ...

6.7. Pregnancy

(See WARNINGS about use during tooth development) Doxycycline for Injection has not been studied in pregnant patients. It should not be used in pregnant women unless, in the judgment of the physician, ...

6.10. Pediatric Use

The use of Doxycycline for Injection in children under 8 years is not recommended because safe conditions for its use have not been established. Because of the effects of drugs of the tetracyclineclass ...

7. Adverse Reactions

Gastrointestinal Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis and inflammatory lesions (with monilial overgrowth) in the anogenital region, and pancreatitis. Hepatotoxicity ...

10. Dosage and Administration

NOTE: Rapid administration is to be avoided. Parenteral therapy is indicated only when oral therapy is not indicated. Oral therapy should be instituted as soon as possible. If intravenous therapy ...

11. How Supplied

Doxycycline for Injection, USP, sterile powder, supplied as follows: Product Code Unit of Sale Strength Each NP1311 NDC 63323-130-13 Unit of 10 Doxycycline hyclate ...

12. Storage and Handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT. Retain in carton until time of use.