Moxidectin (Page 5 of 5)
16 HOW SUPPLIED/STORAGE AND HANDLING
Moxidectin Tablets containing 2 mg moxidectin are white to pale yellow uncoated oval-shaped tablets, debossed on one side with “AKKA”. Each high-density polyethylene bottle contains 500 tablets (NDC 71705-050-01), a silica gel desiccant and polyester coil.
Store below 30°C (86°F).
- Protect from light.
- Once open, the full contents of the container should be used within 24 hours with any unused content discarded.
17 PATIENT COUNSELING INFORMATION
Signs and Symptoms Associated with Microfilarial Death
Advise patients that they are likely to have flu like symptoms including malaise, myalgia, headache, tachycardia, hypotension and pruritus, most commonly during the first week after treatment.
Symptomatic Orthostatic Hypotension
Advise patients that if they feel dizzy, faint or light-headed after taking Moxidectin Tablets, they should lie down until the symptoms resolve.
Absence of Macrofilarial Activity
Advise patients that treatment with Moxidectin Tablets does not kill adult O . volvulus and that follow up evaluation is usually required.
Edema and Worsening of Onchodermatitis
Advise patients with hyper-reactive onchodermatitis that they may be more likely to experience severe adverse reactions.
Encephalopathy in Loa loa Co-infected Patients
Advise patients to report any symptoms of encephalopathy to their healthcare provider.
Lactation
Advise women that breastfeeding is not recommended at the time of treatment with Moxidectin Tablets and for 7 days after treatment.
Manufactured for: Medicines Development for Global Health, Melbourne, Victoria, Australia
© 2021 Medicines Development for Global Health. All rights reserved.
PRINCIPAL DISPLAY PANEL
NDC 71705-050-01
moxidectin
tablets
2 mg
500 tablets
Rx Only
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| Labeler — Medicines Development for Global Health (754191398) |
Revised: 01/2022 Medicines Development for Global Health
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