Lomaira

Name: Lomaira

Lomaira Overview

Lomaira is a controlled prescription medication used to enhance weight loss in adults. Lomaira belongs to a group of drugs called anorectics, which may help with appetite suppression.

This medication comes in tablet form and one tablet is taken three times a day, one-half hour before meals.

Common side effects of Lomaira include dry mouth, increased blood pressure, and insomnia. Lomaira can also cause dizziness. Do not drive or operate heavy machinery until you know how Lomaira affects you.

Uses of Lomaira

Lomaira is a controlled prescription medication used to enhance weight loss in adults. It is used in combination with exercise and a reduced-calorie diet to achieve weight reduction.

This medication is approved for adults with a body mass index (BMI) of 30 or more which is considered obese and a BMI of 27 or more which is considered overweight with at least one condition that is related to weight. These conditions include high blood pressure, high cholesterol, and diabetes. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Lomaira Drug Class

Lomaira is part of the drug class:

  • Centrally acting antiobesity products

Side Effects of Lomaira

Serious side effects have been reported with Lomaira. See the "Drug Precautions" section.

Common side effects of phentermine include the following:

  • dry mouth or unpleasant taste
  • diarrhea
  • constipation
  • insomnia
  • increased blood pressure
  • dizziness
  • restlessness

This is not a complete list of Lomaira's side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Lomaira Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • monoamine oxidase inhibitors
  • medications for weight loss
  • insulin and medications used to treat diabetes (A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required)
  • adrenergic neuron blocking drugs
  • alcohol

This is not a complete list of Lomaira drug interactions. Ask your doctor or pharmacist for more information.

Lomaira Overdose

If you take too much Lomaira, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

How is this medicine (Lomaira) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take Lomaira early in the day to prevent sleep problems.
  • Take before or after breakfast as your doctor has told you.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Contraindications

• History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension)
• During or within 14 days following the administration of monoamine oxidase inhibitors
• Hyperthyroidism
• Glaucoma
• Agitated states
• History of drug abuse
• Pregnancy (see Precautions)
• Nursing (see Precautions)
• Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines

How supplied/storage and handling

Lomaira™ is available as follows:

Lomaira™ 8 mg is supplied as white butterfly shaped tablets with blue speckles, debossed “K1” on one side and bisected on the other side.

Bottles of 30, NDC 10702-001-03

Bottles of 60, NDC 10702-001-06

Bottles of 90, NDC 10702-001-09

Bottles of 250, NDC 10702-001-25

Bottles of 500, NDC 10702-001-50

Bottles of 1000, NDC 10702-001-10

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Keep out of the reach of children.

Manufactured by:
KVK-Tech, Inc.
110 Terry Drive
Newtown, PA 18940

Item ID# 006178/07
Manufacturer’s Code: 10702 09/16

Package label.principal display panel

30 Tablets

NDC 10702-001-03

LomairaTM CIV

(phentermine hydrochloride USP) tablets

8 mg

30 Tablets Rx Only

KVK-TECH, INC.

60 Tablets

NDC 10702-001-06

LomairaTM CIV

(phentermine hydrochloride USP) tablets

8 mg

60 Tablets Rx only

KVK-TECH, INC.

90 Tablets

NDC 10702-001-09

LomairaTM CIV

(phentermine hydrochloride USP) tablets

8 mg

90 Tablets Rx only

KVK-TECH, INC.

250 Tablets

NDC 10702-001-25

LomairaTM CIV

(phentermine hydrochloride USP) tablets

8 mg

250 Tablets Rx only

KVK-TECH, INC.

500 Tablets

NDC 10702-001-50

LomairaTM CIV

(phentermine hydrochloride USP) tablets

8 mg

500 Tablets Rx only

KVK-TECH, INC.

1000 Tablets

NDC 10702-001-10

LomairaTM CIV

(phentermine hydrochloride USP) tablets

8 mg

Rx only 1000 Tablets

KVK-TECH, INC.

Lomaira 
phentermine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10702-001
Route of Administration ORAL DEA Schedule CIV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE HYDROCHLORIDE 8 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
STEARIC ACID  
FD&C BLUE NO. 1  
SUCROSE  
Product Characteristics
Color WHITE, BLUE (Speckles) Score 2 pieces
Shape FREEFORM (Butterfly Shape) Size 3mm
Flavor Imprint Code K;1
Contains     
Packaging
# Item Code Package Description
1 NDC:10702-001-03 30 TABLET in 1 BOTTLE
2 NDC:10702-001-06 60 TABLET in 1 BOTTLE
3 NDC:10702-001-09 90 TABLET in 1 BOTTLE
4 NDC:10702-001-25 250 TABLET in 1 BOTTLE
5 NDC:10702-001-50 500 TABLET in 1 BOTTLE
6 NDC:10702-001-10 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203495 09/12/2016
Labeler - KVK-TECH, INC. (173360061)
Registrant - AVANTHI INC. (832316694)
Establishment
Name Address ID/FEI Operations
KVK-TECH, INC. 173360061 MANUFACTURE(10702-001)
Revised: 09/2016   KVK-TECH, INC.

What other drugs will affect Lomaira?

Taking Lomaira together with other diet medications such as fenfluramine (Phen-Fen) or dexfenfluramine (Redux) can cause a rare fatal lung disorder called pulmonary hypertension. Do not take this medicine with any other diet medications without your doctor's advice.

Many drugs can affect Lomaira. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 10.01.

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