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  2.1 Dosage Overview for the Treatment of Schizophrenia

  ABILIFY MAINTENA is only to be administered by intramuscular injection by a healthcare professional. The recommended starting and maintenance dose of ABILIFY MAINTENA is 400 mg monthly (no sooner than 26 days after the previous injection).

  For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ABILIFY MAINTENA. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.

  After the first ABILIFY MAINTENA injection, administer oral aripiprazole (10 mg to 20 mg) for 14 consecutive days to achieve therapeutic aripiprazole concentrations during initiation of therapy. For patients already stable on another oral antipsychotic (and known to tolerate aripiprazole), after the first ABILIFY MAINTENA injection, continue treatment with the antipsychotic for 14 consecutive days to maintain therapeutic antipsychotic concentrations during initiation of therapy.

  If there are adverse reactions with the 400 mg dosage, consider reducing the dosage to 300 mg once monthly.

  2.2 Dosage Adjustments for Missed Doses

  If the second or third doses are missed:

  • If more than 4 weeks and less than 5 weeks have elapsed since the last injection, administer the injection as soon as possible . • If more than 5 weeks have elapsed since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection.

  If the fourth or subsequent doses are missed:

  • If more than 4 weeks and less than 6 weeks have elapsed since the last injection, administer the injection as soon as possible. • If more than 6 weeks have elapsed since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection. 2.3 Dosage Adjustments for Cytochrome P450 Considerations

  Dosage adjustments are recommended in patients who are CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for greater than 14 days (see Table 1). Dosage adjustments for 200 mg and 160 mg are obtained only by using the 300 mg or 400 mg strength vials for intramuscular deltoid or gluteal injection.

  If the CYP3A4 inhibitor or CYP2D6 inhibitor is withdrawn, the ABILIFY MAINTENA dosage may need to be increased [see DOSAGE AND ADMINISTRATION (2.1)].

  Avoid the concomitant use of CYP3A4 inducers with ABILIFY MAINTENA for greater than 14 days because the blood levels of aripiprazole are decreased and may be below the effective levels.

  Dosage adjustments are not recommended for patients with concomitant use of CYP3A4 inhibitors, CYP2D6 inhibitors or CYP3A4 inducers for less than 14 days.

  Table 1: Dose Adjustments of ABILIFY MAINTENA in Patients who are known CYP2D6 Poor Metabolizers and Patients Taking Concomitant CYP2D6 Inhibitors, 3A4 Inhibitors, and/or CYP3A4 Inducers for Greater than 14 days Factors Adjusted Dose 1    200 mg and 160 mg dosage adjustments are obtained only by using the 300 mg or 400 mg strength vials.

  CYP2D6 Poor Metabolizers

  Known CYP2D6 Poor Metabolizers

  300 mg

  Known CYP2D6 Poor Metabolizers taking concomitant CYP3A4 inhibitors

  200 mg1

  Patients Taking 400 mg of ABILIFY MAINTENA

  Strong CYP2D6 or CYP3A4 inhibitors

  300 mg

  CYP2D6 and CYP3A4 inhibitors

  200 mg1

  CYP3A4 inducers

  Avoid use

  Patients Taking 300 mg of ABILIFY MAINTENA

  Strong CYP2D6 or CYP3A4 inhibitors

  200 mg1

  CYP2D6 and CYP3A4 inhibitors

  160 mg1

  CYP3A4 inducers

  Avoid use

  ABILIFY MAINTENA comes in two types of kits. See instructions for reconstitution/injection/disposal procedures for 1) Pre-filled Dual Chamber Syringe (2.5), and 2) Vials (2.6).

  2.4 Different Aripiprazole Formulations and Kits

  There are two aripiprazole formulations for intramuscular use with different dosages, dosing frequencies, and indications. ABILIFY MAINTENA is a long-acting aripiprazole formulation with 4 week dosing intervals indicated for the treatment of schizophrenia. In contrast, aripiprazole injection (9.75 mg per vial) is a short-acting formulation indicated for agitation in patients with schizophrenia or mania. Do not substitute these products. Refer to the prescribing information for aripiprazole injection for more information about aripiprazole injection.

  ABILIFY MAINTENA comes in two types of kits. See instructions for reconstitution/injection/disposal procedures for 1) Pre-filled Dual Chamber Syringe available in 300 mg or 400 mg strength syringes [see DOSAGE AND ADMINISTRATION (2.5)], and 2) Single-use vials available in 300 mg or 400 mg strength vials [see DOSAGE AND ADMINISTRATION (2.6)].

  The 200 mg and 160 mg dosage adjustments are obtained only by using the 300 mg or 400 mg strength vials.

  2.5 Pre-filled Dual Chamber Syringe: Preparation and Administration Instructions

  Preparation Prior to Reconstitution

  For deep intramuscular deltoid or gluteal injection by healthcare professionals only. Do not administer by any other route. Inject full syringe contents immediately following reconstitution. Administer once monthly.

  Lay out and confirm that components listed below are provided in the kit:

  • One ABILIFY MAINTENA (aripiprazole) pre-filled dual chamber syringe (400 mg or 300 mg as appropriate) for extended release injectable suspension containing lyophilized powder and Sterile Water for Injection • One 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for deltoid administration in non-obese patients • One 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for gluteal administration in non-obese patients or deltoid administration in obese patients • One 21 gauge, 2 inch (50 mm) hypodermic safety needle with needle protection device for gluteal administration in obese patients

  Reconstitution of Lyophilized Powder in Pre-filled Dual Chamber Syringe

  Reconstitute at room temperature.

  a) Push plunger rod slightly to engage threads. And then, rotate plunger rod until the rod stops rotating to release diluent. After plunger rod is at complete stop, middle stopper will be at the indicator line (See  Figure 1 ).

  Figure 1

  b) Vertically shake the syringe vigorously for 20 seconds until drug is uniformly milky-white (See Figure 2).

  Figure 2

  c) Visually inspect the syringe for particulate matter and discoloration prior to administration. The reconstituted ABILIFY MAINTENA suspension should appear to be a uniform, homogeneous suspension that is opaque and milky-white in color.

  Injection Procedure

  Use appropriate aseptic techniques throughout injection procedure. For deep intramuscular injection only.

  a) Twist and pull off Over-cap and Tip-cap (See Figure 3 ).

  Figure 3

  b) Select appropriate needle (See Figure 4 ).

  Figure 4

  For deltoid administration:

  • 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for non-obese patients • 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for obese patients

  For gluteal administration:

  • 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for non-obese patients • 21 gauge, 2 inch (50 mm) hypodermic safety needle with needle protection device for obese patients c) While holding the needle cap, ensure the needle is firmly seated on the safety device with a push. Twist clockwise until SNUGLY fitted (See Figure 5 ).

  Figure 5

  d) Then PULL needle-cap straight up (see Figure 6).

  Figure 6

  e) Hold syringe UPRIGHT and ADVANCE PLUNGER ROD SLOWLY TO EXPEL THE AIR. Expel air until suspension fills needle base. If it’s not possible to advance plunger rod to expel the air, check that plunger rod is rotated to a complete stop (See Figure 7).

  Figure 7

  f) Inject slowly into the deltoid or gluteal muscle. Do not massage the injection site.

  Disposal Procedure

  a) Engage the needle safety device and safely discard all kit components (See Figure 8). ABILIFY MAINTENA pre-filled dual chamber syringe is for single-use only.

  Figure 8

  b) Rotate sites of injections between the two deltoid or gluteal muscles. 2.6 Vial: Preparation and Administration Instructions

  Preparation Prior to Reconstitution

  For deep intramuscular injection by healthcare professionals only. Do not administer by any other route. Inject immediately after reconstitution. Administer once monthly.

  a) Lay out and confirm that components listed below are provided in the kit: • Vial of ABILIFY MAINTENA (aripiprazole) for extended-release injectable suspension lyophilized powder • 5 mL vial of Sterile Water for Injection, USP • One 3 mL luer lock syringe with pre-attached 21 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device • One 3 mL luer lock disposable syringe with luer lock tip • One vial adapter • One 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for deltoid administration in non-obese patients • One 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for gluteal administration in non-obese patients or deltoid administration in obese patients • One 21 gauge, 2 inch (50 mm) hypodermic safety needle with needle protection device for gluteal administration in obese patients
  b) ABILIFY MAINTENA should be suspended using the Sterile Water for Injection as supplied in the kit. c) The Sterile Water for Injection and ABILIFY MAINTENA vials are for single-use only. d) Use appropriate aseptic techniques throughout reconstitution and reconstitute at room temperature. e) Select the amount of Sterile Water for Injection needed for reconstitution (see Table 2). Table 2: Amount of Sterile Water for Injection Needed for Reconstitution

  400 mg Vial

  300 mg Vial

  Dose

  Sterile Water for Injection

  Dose

  Sterile Water for Injection

  400 mg

  1.9 mL

  300 mg

  1.5 mL

  Important: There is more Sterile Water for Injection in the vial than is needed to reconstitute ABILIFY MAINTENA (aripiprazole) for extended-release injectable suspension. The vial will have excess Sterile Water for Injection; discard any unused portion.

  Reconstitution of Lyophilized Powder in Vial

  a) Remove the cap of the vial of Sterile Water for Injection and remove the cap of the vial containing ABILIFY MAINTENA lyophilized powder and wipe the tops with a sterile alcohol swab. b) Using the syringe with pre-attached hypodermic safety needle, withdraw the pre-determined Sterile Water for Injection volume from the vial of Sterile Water for Injection into the syringe (see Figure 9). Residual Sterile Water for Injection will remain in the vial following withdrawal; discard any unused portion.

  Figure 9

  c) Slowly inject the Sterile Water for Injection into the vial containing the ABILIFY MAINTENA lyophilized powder (see Figure 10).

  Figure 10

  d) Withdraw air to equalize the pressure in the vial by pulling back slightly on the plunger. Subsequently, remove the needle from the vial. Engage the needle safety device by using the one-handed technique (see Figure 11). Gently press the sheath against a flat surface until the needle is firmly engaged in the needle protection sheath. Visually confirm that the needle is fully engaged into the needle protection sheath, and discard.

  Figure 11

  e) Shake the vial vigorously for 30 seconds until the reconstituted suspension appears uniform (see Figure 12).

  Figure 12

  f) Visually inspect the reconstituted suspension for particulate matter and discoloration prior to administration. The reconstituted ABILIFY MAINTENA is a uniform, homogeneous suspension that is opaque and milky-white in color. g) If the injection is not performed immediately after reconstitution keep the vial at room temperature and shake the vial vigorously for at least 60 seconds to re-suspend prior to injection. h) Do not store the reconstituted suspension in a syringe.

  Preparation Prior to Injection

  a) Use appropriate aseptic techniques throughout injection of the reconstituted ABILIFY MAINTENA suspension. b) Remove the cover from the vial adapter package (see Figure 13). Do not remove the vial adapter from the package.

  Figure 13

  c) Using the vial adapter package to handle the vial adapter, attach the prepackaged luer lock syringe to the vial adapter (see Figure 14).

  Figure 14

  d) Use the luer lock syringe to remove the vial adapter from the package and discard the vial adapter package (see Figure 15). Do not touch the spike tip of the adapter at any time .

  Figure 15

  e) Determine the recommended volume for injection ( Table 3). Table 3: ABILIFY MAINTENA Reconstituted Suspension Volume to Inject 400 mg Vial 300 mg Vial

  Dose

  Volume to Inject

  Dose

  Volume to Inject

  400 mg

  2 mL

  ---

  ---

  300 mg

  1.5 mL

  300 mg

  1.5 mL

  200 mg

  1 mL

  200 mg

  1 mL

  160 mg

  0.8 mL

  160 mg

  0.8 mL

  f) Wipe the top of the vial of the reconstituted ABILIFY MAINTENA suspension with a sterile alcohol swab. g) Place and hold the vial of the reconstituted ABILIFY MAINTENA suspension on a hard surface. Attach the adapter-syringe assembly to the vial by holding the outside of the adapter and pushing the adapter's spike firmly through the rubber stopper, until the adapter snaps in place (see Figure 16).

  Figure 16

  h) Slowly withdraw the recommended volume from the vial into the luer lock syringe to allow for injection (see Figure 17). A small amount of excess product will remain in the vial.

  Figure 17

  Injection Procedure • Detach the luer lock syringe containing the recommended volume of reconstituted ABILIFY MAINTENA suspension from the vial. • Select the appropriate hypodermic safety needle and attach the needle to the luer lock syringe containing the suspension for injection. While holding the needle cap, ensure the needle is firmly seated on the safety device with a push. Twist clockwise until snugly fitted and then pull the needle cap straight away from the needle (see Figure 18).

  For deltoid administration:

  • 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for non-obese patients • 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for obese patients

  For gluteal administration:

  • 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for non-obese patients • 21 gauge, 2 inch (50 mm) hypodermic safety needle with needle protection device for obese patients

  Figure 18

  Slowly inject the recommended volume as a single intramuscular injection into the deltoid or gluteal muscle. Do not massage the injection site.

  Disposal Procedure • Engage the needle safety device as described in Section 2.6, Step (d) of Reconstitution of Lyophilized Powder in Vial and safely discard all kit components (see Figure 8). Dispose of the vials, adapter, needles, and syringe appropriately after injection. The Sterile Water for Injection and ABILIFY MAINTENA vials are for single-use only. • Rotate sites of injections between the two deltoid or gluteal muscles.

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