Prescription Drug Information: LymePak (Page 3 of 4)

14 CLINICAL STUDIES

14.1 Clinical Trial Experience

Doxycycline has been used in clinical practice for early stages of Lyme disease for several decades. Thorough search of the published literature identified 31 studies in which doxycycline treatment was used for the treatment of Lyme disease. Of these 31, three randomized studies evaluating doxycycline treatment in patients with erythema migrans and associated symptoms were identified 1-3. In addition, two natural history studies of Lyme disease evaluated disease progression in patients presenting with erythema migrans and associated symptoms 4,5. Over 200 patients from Lyme-disease hyperendemic areas were enrolled in these five studies, and more than 100 received doxycycline. Evidence of efficacy was derived by comparing the doxycycline treatment in studies using doxycycline 100 mg twice daily for 20-21 days with no treatment in the natural history studies. Clinical resolution of symptoms was defined as absence of objective late manifestations of Lyme disease, specifically those related to the musculoskeletal, nervous, and cardiac systems at 6 months. In comparison to untreated patients, doxycycline-treated patients had a higher response rate at 6 months. Doxycycline-treated patients had a response rate of 75-95% compared to 56-66% in untreated patients.

15 REFERENCES

  1. Dattwyler RJ, Volkman DJ, Conaty SM, Platkin SP, Luft BJ. Amoxycillin plus probenecid versus doxycycline for treatment of erythema migrans borreliosis. Lancet 1990; 336(8728):1404-1406.
  2. Massarotti EM, Luger SW, Rahn DW, Messner RP, Wong JB, Johnson RC et al. Treatment of early Lyme disease. Am J Med 1992; 92(4):396-403.
  3. Dattwyler RJ, Luft BJ, Kunkel MJ, Finkel MF, Wormser GP, Rush TJ et al. Ceftriaxone compared with doxycycline for the treatment of acute disseminated Lyme disease. N Engl J Med 1997; 337(5):289-294.
  4. Steere AC, Hardin JA, Ruddy S, Mummaw JG, Malawista SE. Lyme arthritis: correlation of serum and cryoglobulin IgM with activity, and serum IgG with remission. Arthritis Rheum 1979b; 22(5):471-483.
  5. Steere AC, Malawista SE, Newman JH, Spieler PN, Bartenhagen NH. Antibiotic therapy in Lyme disease. Ann Intern Med 1980; 93(1):1-8.

16 HOW SUPPLIED/STORAGE AND HANDLING

LYMEPAK tablets contain 100 mg of doxycycline (equivalent to 115 mg doxycycline hyclate). The tablets are green, round, film-coated tablets engraved with LP-1 on one side.

NDC # 72135-596-86: is supplied as a child-resistant blister card containing 14 tablets
NDC # 72135-596-87: Unit of use carton containing 3 blister cards, total 42 tablets

Store at 20°C to 25°C (68°F to 77°F) excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

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] .

PATIENT INFORMATION LYMEPAK (LIME-pac) (doxycycline) Tablets, for oral use

Read this Patient Information before you start taking LYMEPAK and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

What is LYMEPAK?

LYMEPAK is a prescription medicine used for the treatment of early Lyme disease due to a bacteria known as Borrelia burgdorferi in adults and children 8 years of age and older weighing 99 pounds (lbs) (45 kg) and above.

It is not known if LYMEPAK is safe and effective in children less than 8 years of age or weighing under 99 lbs (45 kg).

Do not take LYMEPAK if you:

  • are allergic to doxycycline or any of the ingredients in LYMEPAK. See the end of this Patient Information leaflet for a complete list of ingredients in LYMEPAK.

Before you take LYMEPAK tell your doctor about all of your medical conditions including if you:

  • have diarrhea or watery stools.
  • have vision problems.
  • have or had a yeast or fungal infection in your vagina.
  • are pregnant or plan to become pregnant. LYMEPAK may harm your unborn baby. Taking LYMEPAK while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Stop taking LYMEPAK and call your doctor right away if you become pregnant while taking LYMEPAK.
  • are breastfeeding or plan to breastfeed. LYMEPAK can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take LYMEPAK. You and your doctor should decide if you will take LYMEPAK or breastfeed. You should not do both. After the last dose you should not breastfeed for 5 days

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LYMEPAK and other medicines can affect each other causing serious side effects.

Especially tell your doctor if you take:

  • a blood thinner medicine.
  • a penicillin (antibacterial medicine).
  • antacids that contain aluminum, calcium, or magnesium.
  • products containing iron or bismuth subsalicylate.
  • birth control pills. LYMEPAK may reduce the effectiveness of birth control pills. Talk to your doctor about what types of birth control you can use to prevent pregnancy during treatment with LYMEPAK.
  • a medicine taken by mouth that contains isotretinoin or acitretin.
  • a medicine to treat seizures, such as carbamazepine or phenytoin.

How should I take LYMEPAK?

  • Take LYMEPAK exactly as prescribed by your doctor. Taking more than your prescribed dose may increase your risk of side effects, including the risk that bacteria will become resistant to LYMEPAK.
  • Take 1 LYMEPAK tablet every 12 hours
  • Take LYMEPAK with enough fluid to completely swallow the tablet and avoid taking LYMEPAK less than 30 minutes before going to bed to lower your risk of getting irritation or ulcer in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.
  • If irritation of the stomach happens, LYMEPAK may be taken with food or milk.
  • If you took too much LYMEPAK stop taking LYMEPAK and call your doctor right away or go to the nearest hospital emergency room.
  • Your doctor may do blood tests during treatment with LYMEPAK to check for side effects.

What should I avoid while taking LYMEPAK?

Avoid sunlight or artificial sunlight, such as a tanning booth or sunlamp. You could get severe sunburn. Use sunscreen and wear clothes that cover your skin while out in sunlight. Stop taking LYMEPAK and tell your doctor right away if you get sunburn.

What are the possible side effects of LYMEPAK?

LYMEPAK may cause serious side effects, including:

  • Harm to an unborn baby. See ” What should I tell my doctor before taking LYMEPAK?
  • Harm to infants and children under 8 years of age:
    • Permanent teeth discoloration. LYMEPAK may permanently turn a baby or child’s teeth yellow-gray-brown during tooth development.
    • Slow bone growth. LYMEPAK may slow bone growth in infants and children. Slow bone growth is reversible after stopping treatment with LYMEPAK.
  • Diarrhea. Diarrhea can happen with most antibiotics, including LYMEPAK. This diarrhea may be caused by an infection ( Clostridium difficile) in your intestines. Call your doctor right away if you get watery or bloody stools, this can happen anytime while on LYMEPAK, or even two or more months after taking your last dose.
  • Severe Skin Reactions Stop taking LYMEPAK and tell your doctor right away if you get any of the following symptoms during treatment with LYMEPAK:
    • rash with red, purple, blue or gray discoloration with fever
    • tiredness
    • cough
    • trouble breathing
    • feeling uneasy
    • itching or burning eyes
    • sensitivity to light
    • joint pain
    • painful skin with blisters
    • skin peeling (chest, face, palms of the hands or soles of the feet)
    • sores or ulcers (mouth, eyes, vagina or penis)
    • swollen lymph nodes
  • Jarisch-Herxheimer Reaction. This reaction can happen in people with early Lyme Disease and begins one to two hours after the first dose of LYMEPAK and disappears within 12 to 24 hours. The reaction may include fever, chills, muscle pain, headache, worsening of skin lesions, fast heart rate, fast breathing, flushing of skin, and increase in blood pressure. Tell your doctor if you have any of these symptoms.
  • Increased pressure around the brain (intracranial hypertension). This condition may lead to vision changes and permanent vision loss. You may be more likely to get intracranial hypertension if you are female of childbearing age and are overweight or have a history of intracranial hypertension. Stop taking LYMEPAK and call your doctor right away if you have blurred or double vision, vision loss, or unusual headaches.

If you have any of the above serious side effects during treatment with LYMEPAK, your doctor may stop your treatment.

Common side effects of LYMEPAK include:

  • nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • skin sensitivity to sunlight
  • rash
  • hives
  • headache
  • reversible discoloration of the surface of adult teeth
  • lower than normal amount of red blood cells

These are not all the possible side effects of LYMEPAK.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store LYMEPAK?

  • Store LYMEPAK at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep LYMEPAK inside blister dose card and out of light.
  • Keep LYMEPAK away from moisture

Keep LYMEPAK and all medicine out of the reach of children.

General information about the safe and effective use of LYMEPAK

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take LYMEPAK for a condition for which it was not prescribed. Do not give LYMEPAK to other people, even if they have the same symptoms you have. It may harm them. You can also ask your doctor or pharmacist for information that is written for health professionals.

What are the ingredients in LYMEPAK?

Active ingredient: doxycycline

Inactive ingredients: anhydrous lactose, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C yellow #6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide.

Manufactured By:
Chartwell Pharmaceuticals, LLC.
Congers, NY 10920 USA

Manufactured For:
Lifsa Drugs LLC
New Brunswick, NJ 08901 USA

Made in USA

L70364

For more information, go to www.lymepak.com or call 1-845-232-1683.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 09/2021

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.