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Rx Item-Apidra Pen insulin glulisine Sq 100U/ml Solo Star5X3ml by Aventis Refrig

RX147843 147843 NDC No.00088-2502-05 00088250205 0088-2502-05 0088250205 UPC/GTIN No.3-00882-50205-1 300882502051 300882-502051 MPN 250205 RX147843 147843 NDC No.00088-2502-05 00088250205 0088-2502-05 0088250205 UPC/GTIN No.3-00882-50205-1 300882502051 300882-502051 MPN 250205 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Apidra Pen insulin glulisine Sq 100U/ml Solo Star5X3ml by Aventis Refrig

$658.22$599.99

RX147843 147843 NDC No.00088-2502-05 00088250205 0088-2502-05 0088250205 UPC/GTIN No.3-00882-50205-1 300882502051 300882-502051 MPN 250205 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No.Rx147843 Apidra Pen 100/ml 5X3ml by Aventis Pharm Refrig Item No.3147843 NDC No.00088250205 UPC No.300882502051

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Clinical Information
Gen. Code and Des.
60371 insulin glulisine SUBCUT INSULN PEN 100/ML
GCN and Des.
26508 insulin glulisine SUBCUT INSULN PEN 100/ML
Strength
Dose Form
INSULIN PEN (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
68200804 RAPID-ACTING INSULINS
68200800 INSULINS
Active Ingredients
10953 insulin glulisine 207748296
Inactive Ingredients
2551 polysorbates 9005645
3199 phenol 108952

APIDRA- insulin glulisine injection, solution
APIDRA SOLOSTAR- insulin glulisine injection, solution
Sanofi-Aventis U.S. LLC
APIDRA? (insulin glulisine [rDNA origin] injection) is rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid. Chemically, insulin glulisine is 3B -lysine-29B -glutamic acid-human insulin, has the empirical formula C258 H384 N64 O78 S6 and molecular weight of 5823
Mechanism of action
Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin glulisine. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.
The glucose lowering activities of APIDRA and of regular human insulin are equipotent when administered by the intravenous route. After subcutaneous administration, the effect of APIDRA is more rapid in onset and of shorter duration compared to regular human insulin

APIDRA is sterile, aqueous, clear, and colorless solution. Each milliliter of APIDRA contains 100 units (3.49 mg) insulin glulisine, 3.15 mg metacresol, mg tromethamine, mg sodium chloride, 0.01 mg polysorbate 20, and water for injection. APIDRA has pH of approximately 7.3. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide.

INDICATIONS AND USAGE
APIDRA is indicated to improve glycemic control in adults and children with diabetes mellitus.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage considerations
APIDRA is recombinant insulin analog that is equipotent to human insulin (i.e. one unit of APIDRA has the same glucose-lowering effect as one unit of regular human insulin) when given intravenously. When given subcutaneously, APIDRA has more rapid onset of action and shorter duration of action than regular human insulin.
The dosage of APIDRA must be individualized. Blood glucose monitoring is essential in all patients receiving insulin therapy.
The total daily insulin requirement may vary and is usually between 0.5 to Unit/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs.
2.2 Subcutaneous administration
APIDRA should be given within 15 minutes before meal or within 20 minutes after starting meal.
APIDRA given by subcutaneous injection should generally be used in regimens with an intermediate or long-acting insulin.
APIDRA should be administered by subcutaneous injection in the abdominal wall, thigh, or upper arm. Injection sites should be rotated within the same region (abdomen, thigh or upper arm) from one injection to the next to reduce the risk of lipodystrophy [See Adverse Reactions ].
2.3 Continuous subcutaneous infusion (insulin pump)
APIDRA may be administered by continuous subcutaneous infusion in the abdominal wall. Do not use diluted or mixed insulins in external insulin pumps. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy [See Adverse Reactions ]. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen.
The following insulin pumps have been used in APIDRA clinical trials conducted by sanofi-aventis, the manufacturer of APIDRA:
Disetronic? H-Tron? plus V100 and D-Tron? with Disetronic catheters (Rapid?, Rapid C?, Rapid D?, and Tender?)
MiniMed? Models 506, 507, 507c and 508 with MiniMed catheters (Sof-set Ultimate QR?, and Quick-set?).
Before using different insulin pump with APIDRA, read the pump label to make sure the pump has been evaluated with APIDRA.
Physicians and patients should carefully evaluate info. on pump use in the APIDRA prescribing info., Patient info. Leaflet, and the pump manufacturer?s manual. APIDRA-specific info. should be followed for in-use time, frequency of changing infusion sets, or other details specific to APIDRA usage, because APIDRA-specific info. may differ from general pump manual instructions. Failure to follow APIDRA-specific instructions may lead to serious adverse events.
Patients administering APIDRA by continuous subcutaneous infusion must have an alternative insulin delivery system in case of pump system failure.
Based on in vitro studies which have shown loss of the preservative, metacresol and insulin degradation, APIDRA in the reservoir should be changed at least every 48 hours. APIDRA should not be exposed to temperatures greater than 98.6?F (37?C). Intravenous administration
APIDRA can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and serum potassium to avoid hypoglycemia and hypokalemia. For intravenous use, APIDRA should be used at concentrations of 0.05 Units/mL to Unit/mL insulin glulisine in infusion systems using polyvinyl chloride (PVC) bags. APIDRA has been shown to be stable only in normal saline solution (0.9% sodium chloride). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer insulin mixtures intravenously.
3 DOSAGE FORMS AND STRENGTHS
APIDRA 100 units per mL (U-100) is available as:
10 mL vials
3 mL SoloStar prefilled pen
4 CONTRAINDICATIONS
APIDRA is contraindicated:
during episodes of hypoglycemia
in patients who are hypersensitive to APIDRA or to any of its excipientsWhen used in patients with known hypersensitivity to APIDRA or its excipients, patients may develop localized or generalized hypersensitivity reactions
DRUG INTERACTIONS
A number of drugs affect glucose metabolism and may necessitate insulin dose adjustment and particularly close monitoring.
Drugs that may increase the blood glucose-lowering effect of insulins including APIDRA, and therefore increase the risk of hypoglycemia, include oral antidiabetic products, pramlintide, ACE inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates, somatostatin analogs, and sulfonamide antibiotics.
Drugs that may reduce the blood-glucose-lowering effect of APIDRA include corticosteroids, niacin, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), glucagon, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), protease inhibitors, and atypical antipsychotics.
Beta-blockers, clonidine, lithium salts, and alcohol may either increase or decrease the blood-glucose-lowering effect of insulin.
Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
The signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs such as beta-blockers, clonidine, guanethidine, and reserpine.
Pregnancy
Pregnancy Category C:
How supplied
APIDRA 100 units per mL (U-100) is available as:
10 mL vials
NDC 0088-2500-33
3 mL SoloStar prefilled pen, package of 5
NDC 0088-2502-05
Pen needles are not included in the packs.
SoloStar is compatible with all pen needles from Becton Dickinson and Company, Ypsomed and Owen Mumford.
16.2 Storage
Do not use after the expiration date (see carton and container).
Unopened Vial/ SoloStar
Unopened APIDRA vials and SoloStar should be stored in refrigerator, 36?F?46?F (2?C?8?C). Protect from light. APIDRA should not be stored in the freezer and it should not be allowed to freeze. Discard if it has been frozen.
Unopened vials/SoloStar not stored in refrigerator must be used within 28 days.


RX147843 147843 NDC No.00088-2502-05 00088250205 0088-2502-05 0088250205 UPC/GTIN No.3-00882-50205-1 300882502051 300882-502051 MPN 250205
Apidra Pen 100U/ml 5X3ml by Aventis Phar
RX147843 147843 NDC No.00088-2502-05 00088250205 0088-2502-05 0088250205 UPC/GTIN No.3-00882-50205-1 300882502051 300882-502051 MPN 250205

RX147843 147843 NDC No.00088-2502-05 00088250205 0088-2502-05 0088250205 UPC/GTIN No.3-00882-50205-1 300882502051 300882-502051 MPN 250205
Apidra Pen 100U/ml 5X3ml by Av
RX147843 147843 NDC No.00088-2502-05 00088250205 0088-2502-05 0088250205 UPC/GTIN No.3-00882-50205-1 300882502051 300882-502051 MPN 250205

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
INSULIN GLULISINE SUB-Q I
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.