Doxyclycline Hyclate
Generic Name: doxyclycline hyclate
Brand Names:
Doxycycline Hyclate
11 DESCRIPTION Doxycycline Hyclate Tablets USP contain doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C 22 H 24 N 2 O 8 ●HCl) 2 ●C 2 H 6 O●H 2 O and the molecular weight of doxycycline hyclate is 1025.87.
Overview
11 DESCRIPTION Doxycycline Hyclate Tablets USP contain doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C 22 H 24 N 2 O 8 ●HCl) 2 ●C 2 H 6 O●H 2 O and the molecular weight of doxycycline hyclate is 1025.87.
Uses
1 INDICATIONS AND USAGE Doxycycline hyclate tablet is a tetracycline class drugs indicated for: Rickettsial infections ( 1.1 ) Sexually transmitted infections ( 1.2 ) Respiratory tract infections ( 1.3 ) Specific bacterial infections ( 1.4 ) Ophthalmic infections ( 1.5 ) Anthrax, including inhalational anthrax (post-exposure) ( 1.6 ) Alternative treatment for selected infections when penicillin is contraindicated ( 1.7 ) Adjunctive therapy for acute intestinal amebiasis and severe acne ( 1.8 ) Prophylaxis of malaria ( 1.9 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be c...
Dosage
2 DOSAGE AND ADMINISTRATION ● Important Administration Instructions for Doxycycline Hyclate Tablets Doxycycline hyclate tablets (150 mg) can be broken into two-thirds or one-third to provide a 50 mg and 100 mg strength, respectively. ( 2.1 ) ● Dosage in Adults for Doxycycline Hyclate Tablets : The usual dosage is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg daily. ( 2.1 ) In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
Side Effects
6 ADVERSE REACTIONS Adverse reactions observed in patients receiving tetracyclines include anorexia, nausea, vomiting, diarrhea, rash, photosensitivity, urticaria, and hemolytic anemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions have been identified during clinical trials or post-approval use of tetracycline-class drugs, including doxycycline. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Interactions
7 DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 ) Avoid co-administration of tetracyclines with penicillin. ( 7.2 ) Absorption of tetracyclines, including doxycycline hyclate is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron-containing preparations. ( 7.3 ) Concurrent use of tetracyclines, including doxycycline hyclate may render oral contraceptives less effective. ( 7.4 ) Barbiturates, carbamazepine and phenytoin decrease the half-life of doxycycline.
Warnings
5 WARNINGS AND PRECAUTIONS The use of doxycycline hyclate 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) and enamel hypoplasia Advise the patient of the potential risk to the fetus during pregnancy. ( 2.2 , 5.1 , 8.1 , 8.4 ) The use of doxycycline hyclate during the second and third-trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. Advise the patient of the potential risk to the fetus during pregnancy. ( 5.2 , 8.1 , 8.4 ) Clostridioides difficile -associated diarrhea (CDAD) has been reported. Evaluate patients if diarrhea occurs. 4 CONTRAINDICATIONS Doxycycline hyclate is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. ( 4 ) Doxycycline hyclate is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
Pregnancy
8.1 Pregnancy Risk Summary Doxycycline hyclate, like other tetracycline-class antibacterial drugs, may cause discoloration deciduous teeth, and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy [see Warnings and Precautions ( 5.1 ) and ( 5.2 )]. Available data from published studies over decades have not shown a difference in major birth defect risk compared to unexposed pregnancies with doxycycline exposure in the first trimester of pregnancy (see Data).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Doxycycline Hyclate Tablets USP, 75 mg are light-teal, round, biconvex, film-coated tablets debossed with "LU" on one side and "C80" on the other side. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline.
Frequently Asked Questions
What is Doxyclycline Hyclate used for?▼
1 INDICATIONS AND USAGE Doxycycline hyclate tablet is a tetracycline class drugs indicated for: Rickettsial infections ( 1.1 ) Sexually transmitted infections ( 1.2 ) Respiratory tract infections ( 1.3 ) Specific bacterial infections ( 1.4 ) Ophthalmic infections ( 1.5 ) Anthrax, including inhalational anthrax (post-exposure) ( 1.6 ) Alternative treatment for selected infections when penicillin is contraindicated ( 1.7 ) Adjunctive therapy for acute intestinal amebiasis and severe acne ( 1.8 ) Prophylaxis of malaria ( 1.9 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be c...
What are the side effects of Doxyclycline Hyclate?▼
6 ADVERSE REACTIONS Adverse reactions observed in patients receiving tetracyclines include anorexia, nausea, vomiting, diarrhea, rash, photosensitivity, urticaria, and hemolytic anemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions have been identified during clinical trials or post-approval use of tetracycline-class drugs, including doxycycline. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Can I take Doxyclycline Hyclate during pregnancy?▼
8.1 Pregnancy Risk Summary Doxycycline hyclate, like other tetracycline-class antibacterial drugs, may cause discoloration deciduous teeth, and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy [see Warnings and Precautions ( 5.1 ) and ( 5.2 )]. Available data from published studies over decades have not shown a difference in major birth defect risk compared to unexposed pregnancies with doxycycline exposure in the first trimester of pregnancy (see Data).
What are the important warnings for Doxyclycline Hyclate?▼
5 WARNINGS AND PRECAUTIONS The use of doxycycline hyclate 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) and enamel hypoplasia Advise the patient of the potential risk to the fetus during pregnancy. ( 2.2 , 5.1 , 8.1 , 8.4 ) The use of doxycycline hyclate during the second and third-trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. Advise the patient of the potential risk to the fetus during pregnancy. ( 5.2 , 8.1 , 8.4 ) Clostridioides difficile -associated diarrhea (CDAD) has been reported. Evaluate patients if diarrhea occurs. 4 CONTRAINDICATIONS Doxycycline hyclate is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. ( 4 ) Doxycycline hyclate is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.