Lymepak (doxycycline hyclate)

Dosage of doxycycline hyclate and doxycycline monohydrate is expressed in terms of doxycycline.

Because of differing bioavailability, doxycycline hyclate delayed-release tablets (Doryx(R), Doryx(R) MPC) are not substitutable on a mg-per-mg basis with other oral doxycycline preparations; Doryx(R) and Doryx(R) MPC also are not substitutable for one another on a mg-per-mg basis. When switching from Doryx(R) to Doryx(R) MPC, Doryx(R) 50 mg can be replaced by Doryx(R) MPC 60 mg, and Doryx(R) 100 mg can be replaced by Doryx(R) MPC 120 mg.

Doxycycline hyclate and doxycycline monohydrate are administered orally.

When oral therapy is not feasible, doxycycline hyclate may be administered by slow IV infusion; however, patients should transition to oral therapy as soon as possible. Prolonged IV administration of doxycycline may result in thrombophlebitis.

Doxycycline also has been administered by intrapleural infusion+.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to doxycycline or any tetracycline.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Common adverse effects reported in patients receiving tetracyclines include anorexia, nausea, vomiting, diarrhea, rash, photosensitivity, urticaria, and hemolytic anemia.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Like other tetracyclines, because of the potential effects on tooth development and growth, doxycycline should not be used in children <8 years of age unless other appropriate drugs would be ineffective or are contraindicated. However, the manufacturers, AAP, CDC, and Infectious Diseases Society of America (IDSA) state that use of doxycycline in children <8 years of age can be considered in certain circumstances when the potential benefits outweigh the risks. These circumstances include the treatment or prophylaxis of anthrax (including inhalational anthrax (postexposure)), treatment of moderate to severe cholera, treatment of leptospirosis, and treatment of presumed or confirmed rickettsial infections, including RMSF, Q fever, ehrlichiosis+, and anaplasmosis+.

Doxycycline is recommended by AAP and CDC as the drug of choice for presumed or confirmed Rickettsial infections (including RMSF) or ehrlichiosis+ (including human granulocytotropic anaplasmosis+ and human monocytotropic ehrlichiosis+) in children of any age.

The CDC states that children <8 years of age with uncomplicated malaria may receive a regimen that includes doxycycline (or tetracycline) if other treatment options are not available or not tolerated and the potential benefits outweigh risks.

Despite the paucity of pediatric data, IDSA/American Academy of Neurology (AAN)/American College of Rheumatology (ACR) state that it is prudent to extrapolate the use of single-dose doxycycline prophylaxis of Lyme disease to children. Caregivers should be informed that there is no study of the efficacy of doxycycline prophylaxis for Lyme disease in pediatric patients <12 years of age and that it is still important to monitor pediatric patients who receive doxycycline prophylaxis for symptoms and signs of Lyme disease. IDSA/AAN/ACR and AAP also state that doxycycline is a drug of choice for the treatment of Lyme disease associated with erythema migrans, Lyme meningitis, Lyme carditis, and Lyme arthritis. Although doxycycline generally is not recommended for pediatric patients <8 years of age, AAP states that the drug is considered safe when used for <=21 days in pediatric patients of any age. IDSA/AAN/ACR state that a growing consensus accepts the safety of doxycycline in young children for at least up to 14 days' duration. AAP states that doxycycline is the preferred oral antibiotic treatment for pediatric patients of any age with Lyme disease-associated facial palsy.

There are no adequate and well-controlled studies on the use of doxycycline in pregnant women. There are no human data available to assess the effects of long-term therapy of doxycycline in pregnant women such as that proposed for the treatment of anthrax exposure. There are no available data on the risk of miscarriage following exposure to doxycycline in pregnancy; the effect of tetracyclines on labor and delivery also is not known. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, apprise the patient of the potential hazard to the fetus. The manufacturer states that doxycycline injection has not been studied in pregnant patients and should be used in pregnant patients only if it is essential for the welfare of the patient.

The vast majority of reported experience with doxycycline during human pregnancy is short-term, first-trimester exposure. An expert review of published data on experiences with doxycycline use during pregnancy by the Teratogen Information System (TERIS) concluded based on data assessed as limited to fair that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk; however, the data are insufficient rule out such risk.

Like other tetracycline-class antibacterial drugs, doxycycline may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy. Discoloration of the teeth, which may be permanent, is more common during long-term use of the drug but has been observed following repeated short-term courses.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity also has been noted in animals treated early in pregnancy.

Current CDC guidelines on the treatment of anthrax state that while tetracycline and minocycline are not recommended in pregnant subjects, doxycycline has not been associated with fetal growth delays, infant tooth staining, or maternal fatty liver. The CDC guidelines state that doxycycline is considered a first-line agent for empiric postexposure anthrax prophylaxis, treatment of cutaneous anthrax without signs or symptoms of meningitis, and in combination regimens for the treatment of systemic anthrax with or without meningitis in pregnant adults.

Malaria infection in pregnant women is associated with high risks of maternal and perinatal morbidity and mortality (e.g., miscarriage, premature delivery, low birth weight, congenital infection and/or perinatal death). For the treatment of uncomplicated malaria acquired in areas with chloroquine-resistant P. falciparum in pregnant women, the CDC recommends treatment with artemether-lumefantrine, mefloquine, or a combination of quinine sulfate and clindamycin. For pregnant women diagnosed with uncomplicated malaria caused by P. malariae, P. ovale, chloroquine-sensitive P. vivax, or chloroquine-sensitive P. falciparum infection, prompt treatment with chloroquine or hydroxychloroquine is recommended. For chloroquine-resistant P. vivax infections, artemether-lumefantrine, quinine plus clindamycin, or mefloquine is recommended. However, CDC states that a regimen of quinine in conjunction with doxycycline (or tetracycline) may be used for the treatment of uncomplicated malaria in pregnant women in rare circumstances (e.g., if other treatment options are not available or not tolerated) if benefits outweigh risks. For the treatment of severe malaria in pregnant patients, the CDC recommends treatment with IV artesunate.

The CDC states that doxycycline has been used successfully to treat tickborne rickettsial diseases in pregnant women without adverse effects to the mother; however, follow-up to address potential adverse effects to the fetus has been limited. Data suggest that treatment with doxycycline at the recommended dose and duration for tickborne rickettsial diseases is unlikely to pose a substantial teratogenic risk; however, data are insufficient to rule out such risk. For potentially life-threatening illnesses, such as RMSF and Ehrlichia chaffeensis ehrlichiosis, consideration of disease-related risks for the mother and fetus is of paramount importance.

Tetracyclines are distributed into human milk; however, the extent of absorption of tetracyclines, including doxycycline, by the breast-fed infant is not known.

Short-term use in lactating women is not necessarily contraindicated. The effects of prolonged exposure to doxycycline on breast milk production and on breast-fed neonates, infants, and children are unknown. The American Academy of Pediatrics (AAP) and US Centers for Disease Control and Prevention (CDC) state that maternal use of tetracyclines usually is compatible with breast-feeding since absorption of the drugs by nursing infants is negligible.

Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for doxycycline and any potential adverse effects on the breast-fed child from the drug or the underlying maternal condition. Some manufacturers state that because of the potential for serious adverse reactions in breast-feeding infants from doxycycline, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother. At least one manufacturer states that breast-feeding is not recommended during treatment with doxycycline and for 5 days following the last dose.

Clinical studies of doxycycline did not include sufficient numbers of patients >=65 years of age to determine whether they respond differently from younger adults. Other reported clinical experience has not identified differences in responses between geriatric patients and younger adults.