DORYX MPC 60 mg/1

doxycycline hyclate · TABLET, DELAYED RELEASE · Mayne Pharma Commercial LLC

No Recall HistoryCurrently in Shortage

Plain English

DORYX MPC is a tablet, delayed release containing doxycycline hyclate at 60 mg/1, taken oral. Manufactured by Mayne Pharma Commercial LLC.

Key Facts

Brand Name: DORYX MPC
Generic Name: doxycycline hyclate
NDC Code (Product): 51862-560
Manufacturer: Mayne Pharma Commercial LLC
Strength: 60 mg/1
Dosage Form: TABLET, DELAYED RELEASE
Route: ORAL
Marketing Status
Application #: NDA050795
Marketing Start: 01/02/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug hypersensitivity2,252 reports

fatigue1,681 reports

nausea1,592 reports

pain1,405 reports

rash1,362 reports

headache1,323 reports

off label use1,320 reports

drug ineffective1,301 reports

diarrhoea1,266 reports

vomiting1,242 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE DORYX MPC is a tetracycline class drug 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 in Acute Intestinal Amebiasis and Severe Acne ( 1.8 ) Prophylaxis of Malaria ( 1.9 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, DORYX MPC Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.10 ) 1.1 Rickettsial Infections DORYX MPC is indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae . 1.2 Sexually Transmitted Infections DORYX MPC is indicated for treatment of the following sexually transmitted infections: Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamy…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions: DORYX MPC is not substitutable on a mg per mg basis with other oral doxycyclines. ( 2.1 ) Do not chew or crush tablets. ( 2.1 ) Dosage in Adult Patients The usual dosage of DORYX MPC is 240 mg on the first day of treatment (administered 120 mg every 12 hours) followed by a maintenance dose of 120 mg daily. ( 2.3 ) In the management of more severe infections (particularly chronic infections of the urinary tract), 120 mg every 12 hours is recommended. ( 2.3 ) Dosage in Pediatric Patients For all pediatric patients weighing less than 45 kg with severe or life threatening infections (e.g., anthrax, Rocky Mountain spotted fever), the recommended dosage of DORYX MPC is 2.6 mg per kg of body weight administered every 12 hours. Pediatric patients weighing 45 kg or more should receive the adult dose. ( 2.4 ) For pediatric patients with less severe disease (greater than 8 years of age and weighing less than 45 kg), the recommended dosage schedule of DORYX MPC is 5.3 mg per kg of body weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.6 mg per kg of body weight (given as…

Contraindications

4 CONTRAINDICATIONS DORYX MPC is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. Doxycycline is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. ( 4 )

Drug 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 DORYX MPC is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron-containing preparations ( 7.3 ) Concurrent use of tetracyclines, including DORYX MPC may render oral contraceptives less effective ( 7.4 ) Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline ( 7.5 ) 7.1 Anticoagulant Drugs Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. 7.2 Penicillin Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines, including DORYX MPC in conjunction with penicillin. 7.3 Antacids and Iron Preparations Absorption of tetracyclines including DORYX MPC is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations. 7.4 Oral Cont…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions have been identified during post-approval use of 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. Due to oral doxycycline's virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines: Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, inflammatory lesions (with monilial overgrowth) in the anogenital region, and pancreatitis. Hepatotoxicity has been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of drugs in the tetracycline-class. Most of these patients took medications immediately before going to bed [ see Dosage and Administration (2.1) ]. Skin: Maculopapular and erythematous rashes, Stevens-Johnson syndrome, toxic epidermal nec…

Frequently Asked Questions

What is DORYX MPC used for?

DORYX MPC contains doxycycline hyclate. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.

Is DORYX MPC a controlled substance?

DORYX MPC is not classified as a controlled substance by the DEA.

What is the generic name for DORYX MPC?

The generic name for DORYX MPC is doxycycline hyclate. There are 12 other brand versions of doxycycline hyclate.

What is the NDC code for DORYX MPC 60 mg/1?

The NDC (National Drug Code) for DORYX MPC 60 mg/1 is 51862-560, listed by Mayne Pharma Commercial LLC.

Product NDC

51862-560

Package NDC

51862-560-00

Other Doxycycline Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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