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Introduction About COSPIAQ MET 12.5/500MG TABLET

COSPIAQ MET 12.5/500MG TABLET is a combination of Empagliflozin and Metformin which belongs to the group of medicines called Antidiabetic agents. COSPIAQ MET 12.5/500MG TABLET is indicated for the management of type II diabetes mellitus in addition to diet and exercise among adults who remain unresponsive to therapy with either metformin alone or in combination with other antidiabetic medicines.

COSPIAQ MET 12.5/500MG TABLET can also be used in combination with other medicines (including insulin) to achieve better control of blood sugar level. Type 2 diabetes is a chronic medical condition in which the body does not make enough insulin or the produced insulin does not work well. Symptoms include excessive urination, excessive thirst, hunger, fatigue and blurred vision.

Along management with COSPIAQ MET 12.5/500MG TABLET follow regular exercise and diet plan as advised by your doctor to achieve better results. Avoid consumption of alcohol during management with COSPIAQ MET 12.5/500MG TABLET as it could aggravate your existing disease condition.

Management with COSPIAQ MET 12.5/500MG TABLET must be discontinued for a short time, if you have any conditions that may be associated with dehydration (such as vomiting, diarrhea, fever, exposure to heat or less fluid intake). During management with COSPIAQ MET 12.5/500MG TABLET, your doctor will check your kidney function at least once a year or more frequently especially if you are elderly.

For diabetic patients, it is recommended to check their foot regularly and adhere to any other advice regarding foot care given by your doctor. COSPIAQ MET 12.5/500MG TABLET is generally not recommended for use in pregnant or breastfeeding women, including children and adolescents (aged less than 18 years) due to lack of safety data.

The most common side effects of taking COSPIAQ MET 12.5/500MG TABLET are hypoglycemia (low blood glucose), nausea, vomiting, diarrhea, excessive thirst, change in taste or dizziness. Consult your doctor if any of the side effects worsen.

Uses Of COSPIAQ MET 12.5/500MG TABLET

To manage type II diabetes mellitus in addition to diet and exercise among adults who remain unresponsive to therapy with either metformin alone or in combination with other antidiabetic medicines

How COSPIAQ MET 12.5/500MG TABLET Works

COSPIAQ MET 12.5/500MG TABLET effectively reduces blood glucose levels, where empagliflozin acts by blocking the activity of a protein called sodium glucose co-transporter 2, which is responsible for the tubular reabsorption of glucose into the blood stream and metformin acts by reducing the amount of glucose released into the blood stream by the liver, thus helps in reducing blood glucose levels.

How to use COSPIAQ MET 12.5/500MG TABLET

Always take COSPIAQ MET 12.5/500MG TABLET as directed by your physician. Swallow the medicine as a whole and do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition. Do not stop taking COSPIAQ MET 12.5/500MG TABLET without informing your doctor.

Side Effects Of COSPIAQ MET 12.5/500MG TABLET

Common

signs of low blood glucose levels (such as excessive hunger, headache, shaking, sweating, confusion, anxiety, fast heartbeat)
urinary tract infection (pain or burning sensation while passing urine, cloudy urine, frequent urination, pain in the pelvis or mid-back pain)
dehydration (unusual thirst, fainting or loss of consciousness, lightheadedness or dizziness upon standing)
nausea, vomiting, diarrhea, constipation, stomach pain or loss of appetite
thrush (genital yeast infection)
skin rash, redness or itching with raised bumps or blisters
change in taste
excessive thirst

Uncommon

hives (raised itchy welts on the skin)
painful urination

Stop taking COSPIAQ MET 12.5/500MG TABLET and contact your doctor immediately if you experience any of the following side effects:

severe allergic reactions (such as swelling of the face, lips, mouth, tongue or throat that may lead to difficulty in breathing or swallowing)
symptoms of lactic acidosis (such as vomiting, stomach pain, decreased heartbeat, difficulty in breathing, muscle cramps, general weakness with severe tiredness or reduced body temperature)
symptoms of diabetic ketoacidosis (such as nausea, vomiting, rapid weight loss, stomach pain, excessive thirst, fast and deep breathing, unusual sleepiness or tiredness, confusion, a sweet smell in your breath, a sweet or metallic taste in your mouth or a different odor to your urine or sweat)
symptoms of fournier´s gangrene (such as pain, tenderness, redness or swelling of genitals or area between the genitals and the anus accompanied with fever or general weakness)

How To Manage Side Effects

Constipation

Take fiber rich foods in your diet such as vegetables, whole grain cereals and drink plenty of fluids. Exercise more regularly and stay active. Consult your doctor if the symptom did not improve.

Diarrhea

Drink lot of fluids such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for managing diarrhea. Consult your doctor if the symptom did not improve.

Loss Of Appetite

Eat when you are hungry. Eat smaller meals more often than usual. Snack only when you're hungry. Try to have a nutritious snack that is rich in calories and protein such as dried fruit and nuts. Consult your doctor if the symptom did not improve.

Nausea And Vomiting

Stick to simple meals while taking this medicine. Avoid eating oil rich or spicy foods. Consult your doctor if the symptom did not improve.

Skin rash Or Itching

Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if the symptom did not improve.

Stomach Pain

Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. Do not self-manage on your own and consult your doctor if the symptom did not improve on its own.

Warning & Precautions

Pregnancy

Contraindicated

COSPIAQ MET 12.5/500MG TABLET is not recommended for use in pregnant women. Consult your doctor before taking COSPIAQ MET 12.5/500MG TABLET.

Breastfeeding

Contraindicated

COSPIAQ MET 12.5/500MG TABLET is not recommended for use in breastfeeding women. Consult your doctor before taking COSPIAQ MET 12.5/500MG TABLET.

Driving and Using Machines

Use with Caution

Do not drive or operate any tools or machines if you experience dizziness after taking COSPIAQ MET 12.5/500MG TABLET.

Alcohol

Consult your doctor

Avoid consumption of alcohol while taking COSPIAQ MET 12.5/500MG TABLET since it may increase the risk of lactic acidosis.

Kidney

Contraindicated

COSPIAQ MET 12.5/500MG TABLET is not recommended for use in patients with severe kidney disease. Consult your doctor before taking COSPIAQ MET 12.5/500MG TABLET.

Liver

Contraindicated

COSPIAQ MET 12.5/500MG TABLET is not recommended for use in patients with liver problems. Consult your doctor before taking COSPIAQ MET 12.5/500MG TABLET.

Allergy

Contraindicated

Do not take COSPIAQ MET 12.5/500MG TABLET if you are allergic to Empagliflozin or Metformin.

Heart Disease

Contraindicated

COSPIAQ MET 12.5/500MG TABLET is not recommended for use in patients with heart problems (such as recent heart attack or failure, cardiogenic shock (problems in blood circulation) or abnormal breathing). Consult your doctor before taking COSPIAQ MET 12.5/500MG TABLET.

Use In Pediatrics

Contraindicated

COSPIAQ MET 12.5/500MG TABLET is generally not recommended for use in children and adolescents (under 18 years of age). Consult your child’s doctor for advice.

Use In Geriatrics

Use with Caution

COSPIAQ MET 12.5/500MG TABLET should be used with caution in elderly patients (aged 65 years or above). Your doctor may assess your kidney function more frequently during management with COSPIAQ MET 12.5/500MG TABLET. Consult your doctor before taking COSPIAQ MET 12.5/500MG TABLET.

Others

COSPIAQ MET 12.5/500MG TABLET is not recommended for use if you:

have uncontrolled diabetes with nausea, vomiting, rapid weight loss, diarrhea, lactic acidosis (lactic acid build up in the bloodstream) or ketoacidosis (ketone bodies accumulate in the blood)
have ever had a diabetic pre-coma
have severe systemic infections affecting your lungs or kidneys
have severe dehydration (either due to vomiting or diarrhea)
are alcoholic
have type I diabetes
have an upcoming major surgery

Before taking COSPIAQ MET 12.5/500MG TABLET inform your doctor if you:

need to undergo an examination with iodination contrast agents (Ex. X-ray or scan)

Interactions

A. Drug-Drug interactions:

Before taking COSPIAQ MET 12.5/500MG TABLET inform to your doctor, if you are taking any of these medicines:

diuretics (medicines used to increase urine output) Ex. furosemide, chlorothiazide, hydrochlorothiazide
other medicines used to manage diabetes (Ex. insulin, glipizide, glyburide, glimepiride)
cimetidine (used to manage stomach ulcers)
verapamil, ranolazine (used to manage chest pain)
dolutegravir (used to manage HIV infection)
trimethoprim (used to manage bacterial infection)
isavuconazole (used to manage fungal infection)
crizotinib, olaparib, vandetanib (used to manage certain forms of cancer)
bronchodilators (used to manage asthma) Ex. salbutamol, salmeterol, formoterol, ipratropium
corticosteroids (used to manage inflammation) Ex. dexamethasone, prednisolone
medicines used to manage pain and inflammation (such as ibuprofen and celecoxib)
medicines used to manage high blood pressure (Ex. captopril, enalapril, losartan, valsartan)
medicines containing alcohol (such as cough syrup)
iodinated contrast agents (used during an X-ray or scan)
lithium (used to manage mental illness)

Overdosage:

If you or anyone else accidentally take too much of COSPIAQ MET 12.5/500MG TABLET, contact your doctor immediately or go to a nearest hospital straight away as it could lead to a life-threatening condition called lactic acidosis. Symptoms of lactic acidosis might include nausea, vomiting, stomach pain with muscle cramps, decreased heartbeat, general weakness with severe tiredness, difficulty in breathing or reduced body temperature.

Synopsis

Drug	:	Empagliflozin, Metformin
Pharmacological Category	:	Sodium-glucose co-transporter 2 (SGLT2) inhibitors; Biguanides
Therapeutic Indication	:	Type II diabetes mellitus
Dosage Forms	:	Tablet

More Information

Keep COSPIAQ MET 12.5/500MG TABLET out of reach of children
Store at room temperature

FAQs About COSPIAQ MET 12.5/500MG TABLET

Q: Can I consume alcohol while taking COSPIAQ MET 12.5/500MG TABLET?

A: No, avoid consumption of alcohol while taking COSPIAQ MET 12.5/500MG TABLET since it may increase the risk of lactic acidosis and diabetic ketoacidosis. Before taking COSPIAQ MET 12.5/500MG TABLET inform your doctor if you are alcoholic.

Q: Can COSPIAQ MET 12.5/500MG TABLET makes me feel more tired?

A: Yes, COSPIAQ MET 12.5/500MG TABLET can cause severe tiredness, unusual thirst, lightheadedness or dizziness upon standing in some individuals. Consult your doctor immediately if you experience any unusual symptoms after taking COSPIAQ MET 12.5/500MG TABLET.

Q: Is COSPIAQ MET 12.5/500MG TABLET safe to use in elderly patients?

A: COSPIAQ MET 12.5/500MG TABLET should be used with caution in elderly patients (aged 65 years or above), consult your doctor before taking COSPIAQ MET 12.5/500MG TABLET. Your doctor might check your kidney function at least once a year or more frequently to avoid kidney damage.

Q: Can COSPIAQ MET 12.5/500MG TABLET be used in patients with heart disease?

A: COSPIAQ MET 12.5/500MG TABLET is not recommended for use in patients with heart problems such as recent heart attack or failure, cardiogenic shock (problems in blood circulation) or abnormal breathing. Consult your doctor before taking COSPIAQ MET 12.5/500MG TABLET.

Q: What is COSPIAQ MET 12.5/500MG TABLET used for?

A: COSPIAQ MET 12.5/500MG TABLET is used to manage type II diabetes mellitus in addition to diet and exercise among adults who remain unresponsive to therapy with either metformin alone or in combination with other antidiabetic medicines. It is not recommended for use in patients with type-1 diabetes.

References

1. KD. Tripathi. Insulin, Oral Hypoglycemic Drugs and Glucagon. Essentials of medical pharmacology. Seventh edition. 2013. Page – 275-276 & 278.

2. Gerald G. Briggs and Roger K. Freeman. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 2451-2456.

3. Boehringer Ingelheim. Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients with Type 2 Diabetes. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in February 2016] [Accessed on 27th November 2023] https://clinicaltrials.gov/ct2/show/NCT01719003

4. Boehringer Ingelheim. Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients with Type 2 Diabetes. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in September 2016] [Accessed on 27th November 2023] https://clinicaltrials.gov/ct2/show/NCT01167881

5. Jennifer D Goldman. Combination of Empagliflozin and Metformin Therapy: A Consideration of its Place in Type 2 Diabetes Therapy. NCBI; PMC US National Library of Medicine, National Institute of Health. July 2018. [Accessed on 27th November 2023] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6043932/

6. Matthew J. Levine. Empagliflozin for Type 2 Diabetes Mellitus: An Overview of Phase 3 Clinical Trials. NCBI; PMC US National Library of Medicine, National Institute of Health. August 2017. [Accessed on 27th November 2023] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5543566/

7. Uche Anadu Ndefo, Nicole O. Anidiobi, Efrah Basheer and Angie T. Eaton. Empagliflozin (Jardiance): A Novel SGLT2 Inhibitor for the Treatment of Type-2 Diabetes. NCBI; PMC US National Library of Medicine, National Institute of Health. June 2015. [Accessed on 27th November 2023] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4450666/

8. Samy Hadjadj, Julio Rosenstock, Thomas Meinicke, Hans J Woerle, Uli C Broedl. Initial Combination of Empagliflozin and Metformin in Patients with Type 2 Diabetes. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. October 2016. [Accessed on 27th November 2023] https://pubmed.ncbi.nlm.nih.gov/27493136/

9. Boehringer Ingelheim Pharma GmbH & Co. KG. Electronic Medicines Compendium (EMC). [Revised in January 2021] [Accessed on 27th November 2023] https://www.medicines.org.uk/emc/files/pil.11420.pdf

11. Boehringer Ingelheim Pharmaceuticals, Inc. U.S. Food & Drug Administration. [Revised in December 2016] [Accessed on 27th November 2023] https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s004lbl.pdf

Useful Diagnostic Tests

HbA1C, Also known as Glycated Hemoglobin, Glycosylated Hemoglobin
Blood Glucose Fasting (FBS)
Random Blood Sugar (Rbs)
Post Prandial Blood Sugar (PPBS)
Comprehensive Diabetes Care
Diabetes Screening
Diabetic Profile – Advanced
Diabetes Care Package
Healthians Diabetic Checkup

Author Details

Written By Dr. R. Dinesh John Rajkumar - Pharm.D

Reviewed For Accuracy By Dr. Jaya Prabakaran - MBBS, MD (Diabetology and Family Medicine)

Last updated on 27 Nov 2023 | 06:06 PM(IST)