LymePak Doxycycline Hyclate

Brand Name: LymePak

Generic Name: DOXYCYCLINE HYCLATE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED

Data Current As Of: 2018-11-15

LYMEPAK is indicated for the treatment of early Lyme disease (as evidenced by erythema migrans) due to Borrelia burgdorferi in adults and pediatric patients 8 years of age and older weighing 45 kg and above.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of LYMEPAK and other antibacterial drugs, LYMEPAK should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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 drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines, including LYMEPAK in conjunction with penicillin.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations. Absorption of tetracyclines is impaired by bismuth subsalicylate.

Concurrent use of tetracycline, including LYMEPAK, may render oral contraceptives less effective.

There have been reports of intracranial hypertension associated with the concomitant use of isotretinoin and doxycycline. Avoid the concomitant use of isotretinoin and LYMEPAK because isotretinoin is also known to cause pseudotumor cerebri (benign intracranial hypertension [see Warnings and Precautions (5.7)].

Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

False elevations of urinary catecholamines may occur due to interference with the fluorescence test.

Important Administration and Safety Information for Patients and Caregivers

Advise all patients taking LYMEPAK:

• to avoid excessive sunlight or artificial ultraviolet light while receiving LYMEPAK and to discontinue therapy if phototoxicity (e.g., skin eruption, etc.) occurs. Sunscreen or sunblock should be considered [see Warnings and Precautions (5.4)].
• to drink fluids liberally along with LYMEPAK to reduce the risk of esophageal irritation and ulceration [see Adverse Reactions (6)].
• that the absorption of tetracyclines is reduced when taken with foods, especially those which contain calcium. However, the absorption of LYMEPAK is not markedly influenced by simultaneous ingestion of food or milk [see Dosage and Administration (2.2)].
• that the absorption of tetracyclines is reduced when taken with antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations [see Drug Interactions (7.3)].
• that the use of LYMEPAK might increase the incidence of vaginal candidiasis [see Warnings and Precautions (5.10)].
• that LYMEPAK can make birth control pills less effective [see Drug Interactions (7.3)].

Tooth Discoloration and Inhibition of Bone Growth

Advise patients that LYMEPAK, like other tetracycline-class drugs, may cause permanent tooth discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy. Tell your healthcare provider right away if you become pregnant during treatment [see Warnings and Precautions (5.1,5.2) and Use in Specific Populations (8.1, 8.4)].

Lactation

Advise women not to breastfeed during treatment with LYMEPAK and for 5 days after the last dose [see Use in Specific Populations (8.2)].

Jarisch-Herxheimer Reaction

Inform patients that a systemic reaction known as the Jarisch–Herxheimer reaction (JHR) may occur within 24 hours of starting LYMEPAK. Symptoms include shaking chills, fever, and intensification of skin rash and usually resolve within several hours. Advise patients to contact their health care provider if symptoms occur [see Warnings and Precautions 5.6].

Development of Resistance

Patients should be counseled that antibacterial drugs, including LYMEPAK should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When LYMEPAK is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by LYMEPAK or other antibacterial drugs in the future [see Warnings and Precautions 5.9].

Diarrhea

Diarrhea is a common problem caused by antibacterial drugs, including LYMEPAK, which usually ends when the antibacterials are discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, advise patients to contact their physician as soon as possible [see Warnings and Precautions 5.3].